Surgical arm positioning systems and methods

ABSTRACT

A surgical arm positioning system has a cable including two end portions coupled to a connection member of a hand grip. The cable and connection member form a continuous loop. The surgical arm positioning system further includes a frame that supports a number of pulleys. The continuous loop is trained around the pulleys. The surgical arm positioning system also includes a tensile resistance member engaged with the cable. The tensile resistance member provides tensile force to the cable to resist movement of the continuous loop relative to the frame, thereby to hold the patient&#39;s arm relatively still during surgery.

The present application claims the benefit, under 35 U.S.C. § 119(e), ofU.S. Provisional Application Nos. 62/060,645, 62/060,674, and62/060,793, which were filed Oct. 7, 2014, U.S. Provisional ApplicationNo. 62/131,500, which was filed Mar. 11, 2015, and U.S. ProvisionalApplication No. 62/236,721, which was filed Oct. 2, 2015, each of theforegoing applications being hereby expressly incorporated by referenceherein in their entireties.

BACKGROUND

The present disclosure relates to a sterile connection for attaching toa patient's limb during surgery. More particularly, the presentdisclosure relates to an apparatus that applies lateral traction to apatient's arm.

Shoulder arthroscopy includes several procedures including rotator cuffrepair, bone spur removal, labrum repair, ligament repair, removal ofinflamed tissue or loose cartilage, and repair for recurrent shoulderdislocation. During such procedures, a patient's arm may be connected toan arm positioning system. Internal or external rotation of the humeralhead may be beneficial for some types of shoulder arthroscopy.

Arm positioning systems known in the art often require multiple staffmembers or extra draping to attach a patient's limbs to a supportdevice. Such systems may require sterile and non-sterile staff to worktogether to attach the limb or require the entire non-sterile device tobe covered with a sterile drape. Furthermore, such systems often requireadjustment of non-sterile components in order to move a patient's arm toa desired location.

Shoulder arthroscopy towers known in the art may have a connection pointfor lateral traction with little adjustability. The connection point mayonly move in a single direction. The tower may have a non-sterilelocking mechanism positioned high above the sterile field, makingadjustments difficult. The locking mechanisms may require users to pulllevers, push buttons, or turn knobs that are difficult to reach in someinstances. Therefore, such shoulder arthroscopy towers are cumbersome touse.

SUMMARY

A surgical arm positioning system, sterile connection, lateraldistraction apparatus, and lateral distraction strap have one or more ofthe features recited in the appended claims and/or the followingfeatures, which, alone or in any combination, may comprise patentablesubject matter:

A surgical arm positioning system that may have a cable is disclosed.The cable may have two end portions coupled to a connection member of ahand grip. The cable and connection member may form a continuous loop.The surgical arm positioning system may further include a frame. Pulleysmay be attached to the frame. The continuous loop may be trained aroundthe pulleys. The surgical arm positioning system may also include atensile resistance member engaged with the cable. Such a tensileresistance member may provide tensile force to the cable to resistmovement of the continuous loop.

In some embodiments, the tensile resistance member may be a clutch. Theclutch may provide a resistive torque to one of the pulleys. The tensileresistance member may also be a weight.

It is contemplated that the two end portions of the cable may form anangle from about 120 to about 180 degrees at the connection member.

According to this disclosure, a patient's arm may be attached to theconnection member. When a patient's arm is attached to the connectionmember, the cable may resist movement along the pulleys. The cableresisting movement may allow the surgical arm positioning system to keepthe patient's arm stationary over about 30 degrees of arm abduction.

In some embodiments, at least one of the pulleys may be adjustable alongthe frame. The pulley(s) adjustable along the frame may resist(s)movement along the frame.

It is contemplated that the surgical arm positioning system may alsoinclude a semi-locked clamp capable of pivoting the frame. Thesemi-locked clamp may provide resistance to rotation of the frame.

The present disclosure also teaches a surgical arm positioning systemthat may have two cable portions. An end of each cable portion may becoupled to a connection member of a hand grip. Additionally, thesurgical arm positioning system may also have a lower assembly and anupper assembly. Further, the assemblies may be coupled to the cableportions. When a patient's arm is attached to the connection member, thelower and upper assemblies may resist movement to keep the armstationary. The assemblies may move relative to the frame in response tomoving a patient's arm.

In some embodiments, movement of the lower assembly may influencemovement of the upper assembly. Additionally, movement of the upperassembly may influence movement of the lower assembly. The distancebetween the assemblies is fixed. The surgical arm positioning system mayhave a connecting rod that fixes the distance between the lower andupper assemblies.

It is contemplated that the cable portions and connection member mayform a continuous loop. Additionally, the lower assembly and upperassembly may each comprise a pulley. The continuous loop may be trainedaround the pulleys. A tensile resistance member may be engaged with thecable portions. The tensile resistance member may provide tensile forceto the cable portions. The tensile force provided to the cable portionsmay resist movement of the continuous loop.

According to this disclosure, the tensile resistance member may comprisea clutch. The clutch may provide a resistive torque to one of thepulleys. In some embodiments, the tensile resistance member may comprisea weight.

It is contemplated that a patient's arm may be attached to theconnection member. When a patient's arm is attached to the connectionmember, the cable may resist movement along the pulleys. Additionally,the assemblies may resist movement along the frame. The cable and theassemblies resisting movement may allow the surgical arm positioningsystem to keep the patient's arm stationary over about 70 degrees of armabduction.

In some embodiments, the surgical arm positioning system may alsoinclude a semi-locked clamp that permits pivoting of the frame. Thesemi-locked clamp may provide resistance to rotation of the frame.

This disclosure also teaches a surgical arm positioning system that mayhave a cable. The cable may have two end portions. The end portions maybe coupled to a connection member of a hand grip. The cable andconnection member may form a continuous loop. The continuous loop may betrained around the pulleys. Additionally, the surgical arm positioningsystem may have a tensile resistance member. The tensile resistancemember may be engaged with the cable. Such a tensile resistance membermay provide tensile force to the cable to resist movement of thecontinuous loop. The surgical arm positioning system may further includea frame. The surgical arm positioning system may have pulleys. Also, thesurgical arm positioning system may have a lower assembly and an upperassembly. The assemblies each may have one of the pulleys. The lower andupper assemblies may be adjustable along the frame. A connecting rod mayfix the distance between the lower and upper assemblies.

In some embodiments, the tensile resistance member may be a clutch. Theclutch may provide a resistive torque to one of the pulleys. The tensileresistance member may also be a weight.

It is contemplated that the two end portions of the cable may form anangle from about 120 to about 180 degrees at the connection member.

According to this disclosure, the surgical arm positioning system mayalso have a connecting rod. The connecting rod may fix the distancebetween the lower and upper pulley assemblies.

It is contemplated that a patient's arm may be attached to theconnection member. When a patient's arm is attached to the connectionmember, the cable may resist movement along the pulleys. Additionally,the assemblies may resist movement along the frame. The cable and theassemblies resisting movement may allow the surgical arm positioningsystem to keep the patient's arm stationary over about 70 degrees of armabduction.

In some embodiments, the surgical arm positioning system may alsoinclude a semi-locked clamp that permits pivoting of the frame. Thesemi-locked clamp may provide resistance to rotation of the frame.

A distraction apparatus for use with a lateral distractor strap isdisclosed. The distraction apparatus may have a beam. The distractionapparatus may also have a wheel bracket coupled to a first end region ofthe beam. The distraction apparatus may also have a brake coupled to thewheel bracket. At least one wheel may be coupled to the wheel bracket.The distraction apparatus may also have an extension bar that extendsand retracts relative to the beam. The extension bar may be positionedover the brake. At least one wheel may guide movement of the extensionbar relative to the beam during extension and retraction. The lateraldistractor strap may hang downwardly from a first end of the extensionbar. Application of a downward force to the lateral distractor strap mayforce the extension bar against the brake to prevent the extension barfrom extending or retracting relative to the beam until the downwardforce is removed.

According to this disclosure, the downward force may include the weightof a patient's arm. In some embodiments, the extension bar may have anI-shaped cross section to provide wheel-receiving tracks on oppositesides of the extension bar. Two wheels may be provided and each wheelmay be coupled to a respective side of the wheel bracket and may beengaged by a respective side of the wheel-receiving tracks of theextension bar.

It is contemplated that the wheel bracket may have a body and two armsextending from opposite sides of the body. The body and the arms maydefine a gap and the two wheels may be coupled to the arms. Both wheelsmay extend into the gap. The gap may also receive the extension bar. Thewheels may be engaged by the wheel-receiving tracks of the extensionbar.

According to this disclosure, opposite ends of the extension bar mayhave stop surfaces. The stop surfaces may limit the range of extensionand retraction of the extension bar relative to the beam.

In some embodiments, the distraction apparatus may also have a platformthat couples the wheel bracket to the first end region of the beam. Thewheel bracket may be rotatable relative to the platform about a firstrotation axis. The distraction apparatus may further have a second brakecoupled to the wheel bracket. The second brake may be positioned over aside of the platform. The side of the platform may extendcircumferentially around the platform and may be centered at the firstrotation axis.

It is contemplated that the distraction apparatus may also have a brakefoot coupled to the wheel bracket. The brake foot may be pivotablerelative to the wheel bracket. The brake may be coupled to the brakefoot. The distraction apparatus may further have a second brake coupledto the brake foot. The second brake may be oriented perpendicular to thefirst brake and positioned over a side of the platform.

According to this disclosure, application of the downward force to thelateral distractor strap may force the second brake against the side ofthe platform to prevent the extension bar from rotating relative to theplatform until after the downward force is removed.

In some embodiments, the distraction apparatus may also have a magneticcatch coupled to a second end of the extension bar opposite the firstend of the extension bar. When the extension bar is fully retracted in astorage position, the magnetic catch may hold the extension baralongside the beam.

It is contemplated that the distraction apparatus may also have a hangerthat couples the lateral distractor strap to the first end of theextension bar and a flange positioned between the first end of theextension bar and the lateral distractor strap. The distractionapparatus may further have a tension meter between the hanger and thelateral distractor strap.

The present disclosure also contemplates a distraction apparatus for usewith a lateral distractor strap. The distraction apparatus may have abeam. The distraction apparatus may also include a platform coupled to afirst end region of the beam. The distraction apparatus may further havean extension bar that rotates relative to the platform. The distractionapparatus may still further have a brake coupled to the extension bar.The brake may be positioned over a side of the platform. The lateraldistractor strap may hang downwardly from a first end of the extensionbar. Application of a downward force to the lateral distractor strap mayforce the brake against the platform to prevent the extension bar fromrotating relative to the platform until the downward force is removed.

According to this disclosure, the downward force may include the weightof a patient's arm. In some embodiments, the extension bar may rotaterelative to the platform about a first rotation axis. The side of theplatform may extend circumferentially around the platform and may becentered at the first rotation axis. The side of the platform may extendabout 180° around the platform.

It is contemplated that the distraction apparatus may also include abracket that couples the platform to the beam. There may be a stud inthe platform. There may also be a hole in the bracket. The hole mayengage the stud such that the bracket is rotatable relative to theplatform.

According to this disclosure, the distraction apparatus may also have awheel bracket that couples the platform to the beam. The distractionapparatus may further include at least one wheel coupled to the wheelbracket. The extension bar may extend and retract relative to the beam.The at least one wheel may guide movement of the extension bar relativeto the beam during extension and retraction. The distraction apparatusmay also have a second brake coupled to the wheel bracket. The extensionbar may be positioned over the second brake.

In some embodiments, the distraction apparatus may also have a brakefoot coupled to the wheel bracket. The brake foot may be pivotablerelative to the wheel bracket. The brake may be coupled to the brakefoot. The distraction apparatus may further have a second brake coupledto the brake foot. The second brake may be oriented perpendicular to thefirst brake. The extension bar may be positioned over the second brake.

According to this disclosure, application of the downward force to thelateral distractor strap may force the second brake against theextension bar against the brake to prevent the extension bar fromextending or retracting relative to the beam until the downward force isremoved.

According to another aspect of the present disclosure, a distractionapparatus for use with a lateral distractor strap is provided. Thedistraction apparatus may include a beam, a wheel bracket coupled to afirst end region of the beam, and a platform coupled to the wheelbracket. A brake foot may be coupled to the wheel bracket and the brakefoot may be pivotable relative to the wheel bracket. A first brake and asecond brake may be coupled to the brake foot. At least one wheel may becoupled to the wheel bracket. The distraction apparatus may further havean extension bar that extends and retracts relative to the beam androtates relative to the platform. The extension bar may be positionedover the first brake. The second brake may be positioned over a side ofthe platform. The at least one wheel may guide movement of the extensionbar relative to the beam during extension and retraction. The lateraldistractor strap may hang downwardly from an end of the extension bar.Application of a downward force to the lateral distractor strap mayforce the extension bar against the first brake to prevent the extensionbar from extending or retracting relative to the beam and may force thesecond brake against the side of the platform to prevent the wheelbracket from rotating relative to the platform until the downward forceis removed.

A sterile hand connection device is disclosed. The sterile handconnection device may attach a patient's arm to a cable adaptor. Thecable adaptor may have a pin and may be connected to two cable ends. Thecable ends may be of a surgical arm positioning system.

The sterile hand connection device may have a buckle that may have asnap feature receiving hole and two wide feature receiving gaps. Thesterile hand connection device also may have a connector that may beoperably attached to the buckle such that the buckle and the connectorare rotationally coupled. The connector may have a distal end and aproximal end. The connector also may have a hook its distal end forattaching to the cable adaptor. The sterile hand connection devicefurther may have a flange separating the cable adaptor from the proximalend of the connector.

According to this disclosure, the sterile hand connection device mayhave a nut engaged with the connector for adjusting the buckle. Theconnector may have a distal end and a proximal end. The connector mayhave a threaded portion adjacent to its distal end. The threaded portionof the connector may be cooperatively engaged with the nut. Theconnector also may have a body adjacent to its proximal end.

In some embodiments, the sterile hand connection device also may have aclip adaptor. The clip adaptor may have a proximal end and a distal end.The distal end of the clip adaptor may have a rim that may define anopening in the distal end of the clip adaptor. The clip adaptor maysurround the body of the connector and may be attached and rotationallycoupled to the buckle. The connector may have a cap at its proximal end.The nut may have a distal end and a proximal end. The proximal end ofthe nut may be in contact with the distal end of the clip adaptor. Whenthe nut is moved proximally by rotation, friction between the rim of theclip adaptor and the cap of the connector may increase. The friction mayrotationally couple the buckle and the connector.

It is contemplated that the sterile hand connection device may also havea knob engaged with the connector for locking the sterile handconnection device to the cable adaptor. The connector may have a distalend and a proximal end. The connector may have a threaded portionadjacent to the distal end of the connector. The threaded portion may becooperatively engaged with the knob. The connector also may have a bodyadjacent to the proximal end of the connector. The sterile handconnection device may have a hook at the distal end of the connector.The knob may be in contact with the cable adaptor such that when theknob is moved distally by rotation the force between the cable adaptorand the hook may increase. This increase in force may lock the connectorto the cable adaptor.

According to the present disclosure, therefore, a sterile hand wrap forattaching a patient's arm to a sterile clip is disclosed. The sterileclip may have a snap feature for connection to a sterile hand connectiondevice. The sterile clip may be for attaching to a sterile handconnection device of a surgical arm positioning system. The sterile handwrap may have a foldable sheet that may have an interior side and anexterior side. The interior side may have a foam material.

The foldable sheet may have a wrist portion that may have at least onewrist strap for wrapping around a patient's wrist. The wrist strap mayhave a wrist strap fastener. The foldable sheet may also have a snapfeature receiving opening for receiving the snap feature. The wriststrap fastener may have a hook material and the exterior of the foldablesheet may have a loop material.

It is contemplated that the sterile hand wrap may have a forearm portionthat may at least one forearm strap for wrapping around a patient'sforearm. The at least one forearm strap may have a forearm strapfastener. The forearm strap fastener may have a hook material and theexterior of the foldable sheet may have a loop material.

In some embodiments, the sterile hand wrap may have two wide featurereceiving indentations. The sterile clip may have two wide features forengaging a sterile hand connection device. The wide feature receivingindentations may be for receiving the wide features.

It is contemplated that the sterile hand wrap may be sterilized byultraviolet irradiation.

The present disclosure also teaches a sterile hand wrap for attaching apatient's arm to a sterile clip. The sterile clip may have a snapfeature for connection to a sterile hand connection device and two widefeatures for engaging a sterile hand connection device. The sterile clipmay be for attaching to a sterile hand connection device of a surgicalarm positioning system. The sterile hand wrap may have a foldable sheetthat may have an interior side and an exterior side. The interior sidemay have a foam material.

The foldable sheet may have a wrist portion that may have at least onewrist strap for wrapping around a patient's wrist. The wrist strap mayhave a wrist strap fastener. The foldable sheet may also have a forearmportion that may have at least one forearm strap for wrapping around apatient's forearm. The forearm strap may have a forearm strap fastener.

In some embodiments, the foldable sheet may include a snap featurereceiving opening for receiving the snap feature and two wide featurereceiving indentations or notches for receiving the wide features.

According to this disclosure, therefore, a sterile clip for attaching apatient's arm to a sterile hand connection device of a surgical armpositioning system is disclosed. The sterile clip may have a body havinga distal end and a proximal end. The sterile clip may also have two cliparms extending from the distal end to the proximal end. The sterile clipmay further have a distal cross portion that may be substantiallyperpendicular to the clip arms and that connects the clip arms. Thedistal cross portion and clip arms may form a hand receiving gap. Thesterile clip may still further have a snap feature for connection to asterile hand connection device. The snap feature may be attached to thedistal cross portion.

It is contemplated that the sterile clip may further have two widefeatures for engaging a sterile hand connection device. The widefeatures may be attached to the distal cross portion. The wide featuresmay be adjacent to the clip arms.

The present disclosure also teaches a sterile clip for attaching apatient's arm to a sterile hand connection device of a surgical armpositioning system. The sterile clip may have a body that may have adistal end and a proximal end. The sterile clip may also have two cliparms extending from the distal end to the proximal end. The sterile clipmay further have a distal cross portion substantially perpendicular tothe clip arms. The distal cross portion may connect the clip arms. Thedistal cross portion and clip arms may form a hand receiving gap. Thesterile clip may still further have a snap feature for connection to asterile hand connection device. The snap feature may be attached to thedistal cross portion.

The sterile clip for attaching a patient's arm to a sterile handconnection device of a surgical arm positioning system may further havea sterile hand wrap for attaching the patient's arm to a sterile clip.The sterile hand wrap may have a foldable sheet that may have aninterior side and an exterior side. The interior side may have a foammaterial. The foldable sheet may have a wrist portion that may have atleast one wrist strap for wrapping around a patient's wrist. The wriststrap may have a wrist strap fastener. The foldable sheet may also havea snap feature receiving opening for receiving the snap feature.

In some embodiments, the sterile clip has two wide features for engaginga sterile hand connection device. The wide features may be to the distalcross portion. The wide features may be adjacent to the clip arms. Thefoldable sheet may have two wide feature receiving indentations forreceiving the wide features.

It is contemplated that the sterile hand wrap may have a forearm portionthat may have least one forearm strap for wrapping around a patient'sforearm. The forearm strap may have a forearm strap fastener.

In some embodiments, the sterile hand wrap may be sterilized byultraviolet irradiation.

Additional features, which alone or in combination with any otherfeature(s), such as those listed above and those listed in the claims,may comprise patentable subject matter and will become apparent to thoseskilled in the art upon consideration of the following detaileddescription of various embodiments exemplifying the best mode ofcarrying out the embodiments as presently perceived.

BRIEF DESCRIPTION OF THE DRAWINGS

The detailed description particularly refers to the accompanyingfigures, in which:

FIG. 1 is a side elevation view of a surgical arm positioning systemshowing a frame secured to an accessory rail of a surgical table by asemi-locked clamp assembly with a patient's arm supported by thesurgical arm positioning system;

FIG. 2A is a side elevation view of the surgical arm positioning systemof FIG. 1 including lower and upper pulley assemblies and a cable in afirst position;

FIG. 2B is a side elevation view of the surgical arm positioning systemof FIG. 1 including lower and upper pulley assemblies and a cable in asecond position;

FIG. 3 is a side elevation view of the surgical arm positioning systemof FIG. 2 showing the lower and upper pulley assemblies in a thirdposition;

FIG. 4 is a perspective view of the surgical arm positioning system ofFIG. 1 showing a lower rod with the lower pulley assembly attached tothe lower rod;

FIG. 5 is a perspective view of the lower pulley assembly;

FIG. 6 is a side elevation view of the upper pulley assembly;

FIG. 7 is a side elevation view of an internal pulley assembly;

FIG. 8 is a perspective view of the semi-locked clamp assembly attachedto the accessory rail of the surgical table and to a lower rod of thesurgical arm positioning system of FIG. 1;

FIG. 9 is a perspective view of internal components of the semi-lockedclamp assembly of FIG. 8 with a clamp body of the semi-locked clampassembly omitted;

FIG. 10 is a perspective view of the internal components of FIG. 9 asviewed from another angle;

FIG. 11 is a side elevation view of the surgical arm positioning systemof FIG. 1 showing a cable trained around the pulleys of the surgical armpositioning system with an upper rod of the frame being omitted and ahandle and a handle pin lever of the internal pulley assembly of FIG. 7being omitted;

FIG. 12 is a side elevation view of a surgical arm positioning system,similar to FIG. 11, showing the surgical arm positioning system having aweight attached to the cable;

FIG. 13 is a perspective view of the surgical arm positioning system ofFIG. 1 showing a latching mechanism that is releasable for folding thesurgical arm positioning system;

FIG. 14 is a side elevation view of a distraction apparatus for use witha lateral distractor strap;

FIG. 15 is an end elevation view of the distraction apparatus of FIG.14;

FIG. 16 is a perspective view of a platform of the distraction apparatusof FIG. 14;

FIG. 17 is a perspective view of an angled bracket of the distractionapparatus of FIG. 14;

FIG. 18 is a perspective view of a lateral distractor strap for use withthe distraction apparatus of FIG. 14;

FIG. 19 is a top plan view of a sleeve member of a lateral distractorstrap;

FIG. 20 is a perspective view of a sterile connection attached to aclip;

FIG. 21 is a side elevation view of the sterile connection and clip ofFIG. 20;

FIG. 22 is a front elevation view of the clip of FIG. 20;

FIG. 23 is a front elevation view of the clip of FIG. 20 showing labelsfor measurements of the clip;

FIG. 24 is a bottom plan view of a buckle of the sterile connection ofFIG. 20;

FIG. 25 is a perspective view of a clip adaptor of the sterileconnection of FIG. 20;

FIG. 26 is a perspective view of a connector of the sterile connectionof FIG. 20;

FIG. 27 is a top plan view of the sterile connection of FIG. 20;

FIG. 28 is a front elevation view of a sterile wrap;

FIG. 29 is a front elevation view of the sterile wrap of FIG. 28 showinglabels for measurements of the sterile wrap;

FIG. 30 is a front elevation view of the sterile wrap of FIG. 28attached to the clip of FIG. 20, the sterile wrap in a partially foldedposition;

FIG. 31 is a rear elevation view of the sterile wrap of FIG. 28 attachedto the clip of FIG. 20, the sterile wrap in the partially foldedposition;

FIG. 32 is a front elevation view of the sterile wrap of FIG. 28attached to the clip of FIG. 20 and wrapped around a patient's wrist ina wrist wrapped position;

FIG. 33 is a rear elevation view of the sterile wrap of FIG. 28 attachedto the clip of FIG. 20 and wrapped around a patient's wrist in a wristwrapped folded position;

FIG. 34 is a rear elevation view of the sterile wrap of FIG. 28 attachedto the clip of FIG. 20 and wrapped around a patient's wrist in a wristforearm wrapped folded position;

FIG. 35 is a perspective view of a T-shaped handle of a sterileconnection;

FIG. 36 is a perspective view of a J-shaped handle of a sterileconnection attached to a sterile handle cover;

FIG. 37 is side elevation view of the J-shaped handle of FIG. 38 withthe sterile handle cover omitted.

FIG. 38 is a side elevation view of a portion of a shoulder distractionapparatus with a lateral distractor strap hanging downwardly therefrom;

FIG. 39 is a partial cross-sectional view of the shoulder distractionapparatus of FIG. 38;

FIG. 40 is a side elevation view showing components of the shoulderdistraction apparatus of FIG. 38 including a wheel bracket, a platformbeneath the wheel bracket, and a brake foot to the right of both thewheel bracket and the platform;

FIG. 41 is a top plan view of the wheel bracket and platform of theshoulder distraction apparatus of FIG. 38;

FIG. 42A is a partial side elevation view of the shoulder distractionapparatus of FIG. 38 with the extension bar in a released, retractedposition;

FIG. 42B is a partial side elevation view of the shoulder distractionapparatus of FIG. 38 with the extension bar in a released, extendedposition;

FIG. 43 is a partial side elevation view of the shoulder distractionapparatus of FIG. 38 with the extension bar in a storage position;

FIG. 44 is a top perspective view of a portion of the shoulderdistraction apparatus of FIG. 38;

FIG. 45 is a perspective view of the surgical arm positioning system ofFIG. 1 showing a lower rod with a pulley carriage having lock knobsinstead of the lower pulley assembly attached to the lower rod;

FIG. 46 is a side elevation view of the pulley carriage of FIG. 45;

FIG. 47 is a perspective view of the pulley carriage of FIGS. 45 and 46;

FIG. 48 is a side elevation view of a second embodiment of the internalpulley assembly of FIG. 7 having a reshaped internal pivot;

FIG. 49 is a perspective view of a modified clamp assembly attached tothe accessory rail of the surgical table and to the lower rod of thesurgical arm positioning system of FIG. 1;

FIG. 50 is a perspective view of internal components of the modifiedclamp assembly of FIG. 49 with a clamp body of the modified clampassembly omitted;

FIG. 51 is another perspective view of internal components of themodified clamp assembly of FIG. 49 with a clamp body of the modifiedclamp assembly omitted;

FIG. 52 is a weight assembly for attaching to the surgical armpositioning system;

FIG. 53 is a weight assembly for attaching to the surgical armpositioning system with weights omitted;

FIG. 54 is a perspective view of the surgical arm positioning system ofFIG. 13 showing the latching mechanism with the reshaped internal pivotof FIG. 48;

FIG. 55 is a perspective view of a second embodiment of a sterileconnection attached to a clip;

FIG. 56 is a side elevation view of the sterile connection and clip ofFIG. 55;

FIG. 57 is a front elevation view of the clip of FIGS. 55 and 56;

FIG. 58 is a bottom plan view of a buckle of the sterile connection ofFIGS. 55 and 56;

FIG. 59 is a perspective view of a clip adaptor of the sterileconnection of FIGS. 55 and 56;

FIG. 60 is a perspective view of a connector of the sterile connectionof FIGS. 55 and 56;

FIG. 61 is a side elevation view of another embodiment of the surgicalarm positioning system of FIG. 1;

FIG. 62 is a perspective view of another embodiment of the pulleycarriage of FIGS. 46 and 47;

FIG. 63 is a perspective view of the pulley carriage of FIG. 62including a handle assembly;

FIG. 64 is a perspective view of the surgical arm positioning system ofFIG. 61 showing a lower rod with the pulley carriage and handle assemblyof FIG. 63;

FIG. 65 is a perspective view of a modified clamp assembly attached tothe accessory rail of the surgical table and to the lower rod of thesurgical arm positioning system of FIG. 61;

FIG. 66 is a perspective view of internal components of the modifiedclamp assembly of FIG. 65 with a mounting plate of the modified clampassembly omitted;

FIG. 67A is a perspective view of the surgical arm positioning system ofFIG. 61 showing the latching mechanism of an internal pivot;

FIG. 67B is a perspective view of the surgical arm positioning system ofFIG. 61 from a different angle showing the latching mechanism of aninternal pivot with a cover omitted;

FIG. 68 is a perspective view of an internal pulley assembly of thesurgical arm positioning system of FIG. 61;

FIG. 69 is a perspective view of the latching mechanism of the internalpivot of FIGS. 67A and 67B;

FIG. 70 is a partial perspective view of the surgical arm positioningsystem of FIG. 61 in a folded position;

FIG. 71 is a partial perspective view of the surgical arm positioningsystem of FIG. 61 in a folded position showing the pulley carriage ofFIG. 63;

FIG. 72 is a front elevation view of another embodiment of the clip ofFIG. 20;

FIG. 73 is a front elevation view of another embodiment of the buckle ofFIG. 24;

FIG. 74 is a perspective view of another embodiment of the connector ofFIG. 26;

FIG. 75 is a perspective view of another embodiment of the sterileconnection of FIG. 20 with a detached clip;

FIG. 76A is a front elevation view of another embodiment of the sterilewrap of FIG. 28 showing labels for measurements of the sterile wrap;

FIG. 76B is a side elevation view of the sterile wrap of FIG. 76Ashowing labels for measurements of the sterile wrap;

FIG. 76C is a sectional view of the sterile wrap of FIG. 76A showinglabels for measurements of the sterile wrap;

FIG. 77 is a perspective view of the sterile wrap of FIGS. 76A-76Cattached to the clip of FIG. 72;

FIG. 78A is a front elevation view of a shield for use with the sterileconnection of FIG. 75;

FIG. 78B is a sectional view of the shield of FIG. 78A;

FIG. 79 is a perspective view of the sterile wrap and clip of FIG. 77;

FIG. 80 is a side elevation view of the sterile wrap and clip of FIG.77;

FIG. 81A is a top plan view of the sterile wrap and clip of FIG. 77showing labels for measurements of the clip;

FIG. 81B is a sectional view of the sterile wrap and clip of FIG. 81;

FIG. 81C is a side elevation view of the sterile wrap and clip of FIG.77 showing labels for measurements of the clip;

FIG. 82 is a perspective view of the sterile wrap and clip of FIG. 77showing steps 1 and 2 of attaching the sterile wrap to a patient's arm;

FIG. 83 is a perspective view of the sterile wrap and clip of FIG. 77showing steps 3 and 4 of attaching the sterile wrap to the patient'sarm;

FIG. 84 is a perspective view of the sterile wrap and clip of FIG. 77partially folded around the patient's arm;

FIG. 85 is a perspective view of the sterile wrap and clip of FIG. 77showing steps 5, 6, and 7 of attaching the sterile wrap to the patient'sarm;

FIG. 86 is an exploded view of the sterile wrap and clip of FIG. 77 andthe shield of FIG. 78;

FIGS. 87A-87I are perspective views of the sterile wrap and clip of FIG.77 showing different steps of folding and packaging the sterile wrap andclip;

FIG. 88 is a side elevation view showing components of anotherembodiment of the shoulder distraction apparatus of FIG. 38 including awheel bracket, a platform beneath the wheel bracket, and a brake foot tothe right of both the wheel bracket and the platform;

FIG. 89 is a perspective view showing components of the shoulderdistraction apparatus of FIG. 88;

FIG. 90 is a perspective view showing components of the shoulderdistraction apparatus of FIG. 88 with the brake foot and a base of thewheel bracket omitted;

FIG. 91 is a perspective view showing components of the shoulderdistraction apparatus of FIG. 88 with the brake foot, mounting bracket,and wheel bracket omitted;

FIG. 92 is a perspective view showing components of the shoulderdistraction apparatus of FIG. 88 with the wheel bracket omitted;

FIG. 93 is a perspective view showing components of the shoulderdistraction apparatus of FIG. 88 showing the base of the wheel bracketwith the brake foot omitted;

FIG. 94 is a perspective view of the shoulder distraction apparatus ofFIG. 88 attached to an end of an upper rod of the surgical armpositioning system of FIG. 61; and

FIG. 95 is a tensiometer that attaches to a hanger of the shoulderdistraction apparatus of FIG. 88.

DETAILED DESCRIPTION

A surgical arm positioning system 8 mounted to a surgical table 102 isshown in FIG. 1. The surgical arm positioning system 8 is adapted toreceive and position a patient's arm during surgery and includes a frame10 (also referred to as a tower) with a lower pulley assembly 20, anupper pulley assembly 22, and a clutch assembly 300 coupled to the frame10. A cable 46 is routed through the pulley assemblies 20 and 22 and theclutch assembly 300 and attached to a connection member 48 for attachingto the patient's arm.

The surgical arm positioning system 8 is configured to resist motion ofthe cable 46, thereby holding the arm in position across a range ofabduction angles. However, by moving the patient's arm, an operator canovercome this resistance to motion. For example, the operator can graspthe patient's arm and move it from a first position having a firstabduction angle 25, shown in FIG. 2A, to a second position having asecond abduction angle 25′, shown in FIG. 2B, and the cable 46 will movealong a plurality of pulleys 30 in response to the movement. Uponreleasing the arm in the second position, the system 8 sufficientlyresists motion to once again stabilize the position of the arm. Byadjusting the patient's arm by only making contact with the arm, theoperator avoids touching non-sterile components of the system 8, thusmaintaining sterility.

Additionally, referring to FIGS. 2A and 3, the lower and upper pulleyassemblies 20 and 22 are adjustable along the frame 10 for access tofurther positions of the arm. For example, a patient's arm can be movedfrom the first position having the first abduction angle 25, shown inFIG. 2A to a third position having a third abduction angle 25″, shown inFIG. 3, corresponding to movement of the pulley assemblies 20 and 22along the directions of arrows 21 and 23, respectively. In someembodiments, the lower and upper pulley assemblies 20 and 22 may move inresponse to the operator moving the patient's arm and may hold thepatient's arm in place due to friction between the pulley assemblies 20and 22 and the frame 10. It is also contemplated that the lower andupper pulley assemblies may be moved by adjusting a handle 28. Bycombining the adjustability of the cable 46 and the pulley assemblies22, the system 8 allows for a wide range of abduction angles. To allowfor additional arm positions, the frame 10 is attached to the surgicaltable 100 by a rotatable clamp 18 that allows the frame 10 to pivotrelative to the surgical table 102.

As shown in FIG. 2A, the frame 10 includes a lower beam 12, an upperbeam 14, an internal pivot 302 connecting the lower and upper beams 12and 14, and a release handle 42. As will be described in further detailbelow, when the operator pulls the release handle 42, a lockingmechanism in the internal pivot 302 releases, allowing the upper beam 14to fold toward the lower beam 12. As shown in FIG. 70, the frame 10 maybe folded for storage when the system 8 is not in use. Referring to FIG.8, the lower rod 12 engages with a semi-locked clamp assembly 18 thatclamps the frame 10 to the distal end 100 of a surgical table 102. Inparticular, semi-locked clamp assembly 18 attaches to an accessory rail101 of the surgical table 102.

Referring now to FIG. 20, the connection member 48 is part of a sterileconnection 600 configured to allow the operator to attach the patient'sarm to the rest of the system 8 while maintaining sterility. The sterileconnection 600 includes a receiving assembly 610 and a clip 700. Thereceiving assembly 610 attaches to the sterile connection member 48 andcan be detached after use for sterilization, as shown in FIG. 75. Insome embodiments, the clip receiving assembly 610 may be resistant tohigh temperatures so that it can be sterilized in an autoclave. A handwrap 800, which is adapted to receive the patient's hand, is coupled tothe clip 700, such as by sewing the hand wrap 800 onto the clip 700, asshown, for example, in FIG. 32. When the patient's hand is secured tothe clip 700 by the hand wrap 800, the operator can attach the clip 700to the clip receiving assembly 610 and, by extension, the rest of thesurgical arm positioning system 8. Illustratively, the clip 700, handwrap 800, or both may be made of inexpensive plastic materials and maybe discarded after use.

Referring again to FIG. 1, the surgical arm positioning system 8 furtherincludes a lateral traction system 400 coupled to the frame 10. As shownin FIG. 14, the lateral traction system 400 includes a hanger 436 and alateral traction strap 500 (shown in FIG. 18) hanging from the hanger436. The lateral traction strap 500 can form a loop around the patient'sarm, for providing a lateral traction force to the arm during a surgicaloperation. Illustratively, the lateral traction strap 500 may be made ofinexpensive plastic materials and may be discarded after use.

The surgical arm positioning system 8 described herein allows fornon-discrete positioning of the patient's arm in the lateral decubitusposition. Specifically, the surgical arm positioning system 8 allows foran expanded abduction range compared to previous towers while keepingtraction forces relatively consistent throughout. The surgical armpositioning system 8 may be used in shoulder arthroscopy.

Additionally, the surgical arm positioning system 8 allows a steriledoctor to adjust a patient's arm directly within a range of motionwithout requiring non-sterile personnel to adjust non-sterile parts ofthe surgical arm positioning system 8. Specifically, the interactionbetween the operator and the surgical arm positioning system 8 does notrequire direct contact with the surgical arm positioning system 8.

Although several illustrative embodiments of the surgical armpositioning system 8 are described herein, it contemplated that variouscomponents of the various embodiments can be substituted for each otherwhen, for example, the components have similar functions.

Referring now to FIGS. 11 and 12, two ends of the cable 46 are attachedto the connection member 48. When the connection member 48 is movedalong the direction of arrow 49, corresponding to changes in theabduction angle 25 of the patient's arm (shown in FIGS. 2A, 2B, and 3),the cable 46 moves along a plurality of pulleys 30 and one or moreclutch pulleys 40. The cable 46 and connection member 48 define acontinuous loop around the free pulleys 30 and the internal clutchpulley 40. The pulleys 30 and 40 route the cable 46 and allow for bothmotion control and force transfer. Starting at the connection member 48,the cable 46 is routed through the lower pulley assembly 20, theinternal pivot 302, the clutch assembly 300, optionally a weight 50having a pulley 30 (shown in FIG. 12), the internal pivot 302 again, andthe upper pulley assembly 22, before returning back to the connectionmember 48 to form a loop.

The lower pulley assembly 20 includes a sled body 26, a pulley swinger32, a pulley 30 a attached to the pulley swinger 32, and four wheels 34attached to the sled body 26, as shown in FIG. 5. The sled body 26includes a gap 29 sized to receive the pulley swinger 32. Opposite thepulley 30 a, the pulley swinger 32 includes an aperture (not shown). Apivot pin (not shown) extends across the gap 29 of the sled body 26,through the aperture of the pulley swinger 32, so that the pulleyswinger 32 is free to pivot about a first axis 31. The pulley 30 arotates about a second axis 33 that is perpendicular to the first axis31. As shown in FIG. 11, the cable 46 passes along the pulley 30 aproximal to the sled body 26. Referring to FIG. 1, when the patient'sarm 6 moves into or out of the plane of the surgical arm positioningsystem 8, such flexion or extension when the patient is on his or herside, the pulley swinger 32 pivots about the first axis 31 in response.

Referring now to FIG. 7, two pulleys 30 b and 30 c are attached to theinternal pivot 302. After passing through the lower pulley assembly 20,the cable 46 passes along pulley 30 b, distal to the internal pivot 302,before reaching the clutch assembly 300. The clutch assembly 300includes a rear pulley mount 306 having two pulleys 30 d and 30 e and aclutch pulley 40 attached thereto. The internal clutch pulley 40 iscommercially available from Dynatect Manufacturing, Inc. of New Berlin,Wis. as Part No. EFO16-4. As shown in FIG. 11, the cable 46 passes alongpulley 30 e, distal to pulley 30 d, followed by the clutch pulley 40. Insome embodiments, the cable 46 may wrap around the clutch pulley 40 onetime or multiples times, such as two, three, or four times. Embodimentshaving cable 46 only partially wrapped (e.g., less than) 360° around oneor more of pulleys 30, 40 are also within the scope of this disclosure.After passing along, and possibly wrapping around the clutch pulley 40,the cable 46 passes along pulley 30 d, distal to 30 e and continues pastpulley 30 c, distal to pulley 30 b, to the upper pulley bracket 22.

Movement of the cable 46 is restricted by the application of a resistivetorque created by the internal clutch pulley 40. This tensile resistanceis sufficient to resist motion of the cable 46, thereby holding the armin position across a range of abduction angles. However, by moving thepatient's arm, an operator can overcome this resistance to motion. Afteradjusting the position of the patient's arm, the resistance of cable 46is sufficient that the cable 46 and pulleys 30, 40 reach a state ofequilibrium and the patient's arm is held in place. The resistive torqueof the internal clutch pulley 40 and other resistance to movement of thecable 46 allows the system to achieve equilibrium in a consistent manneracross a wider range of abduction angles, within a given envelope ofmovement, as compared to prior art systems. Illustratively, due toinclusion of internal clutch pulley 40 in the surgical arm positioningsystem 8, about 30 degrees of adjustability of arm abduction ispossible. This is an improvement over systems that have no internalclutch pulley 40 or other resistance member in which only about 10degrees of adjustability of arm abduction may be possible. This range ofadjustability is independent of the movement of other components of thesurgical arm positioning system, which may further extend the range ofadjustability.

In some embodiments, the internal clutch pulley 40 may be replaced by aweight with one or more pulleys 30 f attached thereto, as shown in FIG.12. It is contemplated that the weight may be an adjustable weightsystem 1500, as discussed in further detail below. Embodiments havingone or more internal clutch pulleys 40 and the weight 50 are also withinthe scope of the present disclosure.

One skilled in the art will appreciate that the surgical arm positioningsystem may include any number of internal clutch pulleys 40 and freepulleys 30 capable of restricting movement of cable 46 to a desiredextent. Thus, in some embodiments, more than one internal clutch pulley40 is used. In other embodiments, free pulleys 30 may be used withoutthe use of an internal clutch pulley 40.

Referring now to FIG. 6, the upper pulley assembly 22 includes a sledbody 36, a pulley swinger 32, a pulley 30 f attached to the pulleyswinger 32, and four wheels 34 attached to the sled body 36. The sledbody 26 includes a gap 39 sized to receive the pulley swinger 32.Opposite the pulley 30 a, the pulley swinger 32 includes an aperture(not shown). A pivot pin (not shown) extends across the gap 39 of thesled body 36, through the aperture of the pulley swinger 32, so that thepulley swinger 32 is free to pivot about a first axis 37. The pulley 30g rotates about a second axis 43 that is perpendicular to the axis 37.As shown in FIG. 11, the cable 46 passes along the pulley 30 g proximalto the sled body 36. Referring to FIG. 1, when the patient's arm 6 ismoves into or out of the plane of the surgical arm positioning system 8,such flexion or extension when the patient is on his or her side, thepulley swinger 32 pivots about the first axis 37 in response. Afterpassing along pulley 30 g, the cable 46 reaches the connection member48.

The surgical arm positioning system 8 is configured such that the cable46 forms an angle between 120 and 180 degrees at connection member 48.In some embodiments, the angle is between about 120 and about 180degrees. In further embodiments, the angle is about 110, about 115,about 120, about 125, about 130, about 135, about 140, about 145, about150, about 155, or about 160 degrees. One skilled in the art willappreciate that the surgical arm positioning system 8 may be configuredsuch that the cable forms a variety of angles and is not limited to theangles recited herein. Accordingly, any angle that creates a forcevector such that the tensile force in the cable 46 is transferred to thearm of a patient is within the scope of the present disclosure.

The connection member 48 may be attached directly or indirectly to apatient's arm. In some embodiments, the connection member 48 includes,or is configured to receive, a hand grip. When the patient's arm isattached to connection member 48, the cable 46 is under constant tensiondue to at least the weight of the patient's arm, the system reaches astate of equilibrium, and the patient's arm is held in place.Accordingly, the cable 46 is configured in a manner to apply a tractionforce to the patient's arm. Details of connection member 48 and theassociated hand grip can be found below.

Referring again to FIGS. 2A, 2B, and 3, the lower pulley assembly 20 isconnected to the lower rod 12 and an upper pulley assembly 22 isconnected to the upper rod 14 such that the lower and upper pulleyassemblies 20 and 22 can move about the lower and upper rods 12 and 14,respectively. The lower pulley assembly 20 and upper pulley assembly 22are linked by a connecting rod 24 such that movement of the lower pulleyassembly 20 or the upper pulley assembly 22 results in movement of theother. The connecting rod 24 maintains a consistent distance betweenassemblies 20 and 22 as they move along respective rods 12 and 14. Asthe lower and upper pulley assemblies 20 and 22 are moved along theframe 10, the connecting rod 24 pivots at its points of attachment tothe lower and upper pulley assemblies 20 and 22. It is to be appreciatedthat in some embodiments two or more connecting rods may extend betweenassemblies 20 and 22.

The lower rod 12 and the upper rod 14 include rails 38 as shown in FIG.4 with regard to lower rod 12. In some embodiments, the lower and upperrods 12 and 14 are extrusions having cutout portions resulting in therails 38. The rails 38 of lower rod 12 interact with the lower pulleyassembly 20 such that the wheels 34 are held within lower rod 12 by therails 38 and the lower pulley assembly 20 can move along the length oflower rod 12. Similarly, the rails 38 of upper rod 14 interact with theupper pulley assembly 22 such that the wheels 34 are held within upperrod 14 by the rails 38 and the upper pulley assembly 22 can move alongthe length of upper rod 14.

Still referring to FIG. 4, the lower pulley assembly 20 and the upperpulley assembly 22 can be adjusted by a handle 28. For example, thecaregiver or clinician can grip the handle 28 when making theadjustments in the positions of lower and upper pulley assemblies 20 and22.

In further embodiments, the lower pulley assembly 20 and the upperpulley assembly 22 may be adjusted by moving the patient's arm directly.The surgical arm positioning system 8 responds to movement of thepatient's arm without the operator contacting the system 8.Illustratively, movement of the lower pulley assembly 20 and the upperpulley assembly 22, may be resisted to an extent such that when thepatient's arm is attached, the resistance is sufficiently weak to beovercome by a clinician to change the position of the lower pulleyassembly 20 and the upper pulley assembly 22 as shown in FIGS. 2A and 3and thus adjust the patient's arm. After adjusting the arm, theresistance is sufficient that the lower pulley assembly 20 and the upperpulley assembly 22 reach a state of equilibrium and the patient's arm isheld in place. The adjustment is made in one motion, with both the lowerpulley assembly 20 and the upper pulley assembly 22 moving together.

By linking the movement of the lower pulley assembly 20 and the upperpulley assembly 22, along lower rod 12 and upper rod 14, respectively,the surgical arm positioning system allows for a broader range of armabduction angles compared to allowing the pulley assemblies 20 and 22 tomove independent of each other. As shown in FIGS. 2A and 3, when pulleyassemblies 20, 22 are attached and move along the lower rod 12 and theupper rod 14, respectively, the angle formed at the connection member 48by the ends of the cable 46 is constant compared to the assembliesmoving independent of each other, allowing the system 8 to maintain arelatively consistent force vector over a broader range of motion.

The broad range of adjustability of arm abduction angles 25 (shown inFIG. 2A) associated with linking the movement of the lower pulleyassembly 20 and the upper pulley assembly 22 expands upon the broaderrange of adjustability of arm abduction angles associated with resistivemotion of the continuous loop defined by the cable 46 and connectionmember 48. The combination of both adjustment mechanisms allows theoverall arm abduction range of the surgical arm positioning system to beexpanded while keeping traction forces to the patient's arm relativelyconsistent. Similarly, allowing the lower pulley assembly 20 and theupper pulley assembly 22 to move along lower and upper rods 12 and 14,respectively, results in the surgical arm positioning system 8maintaining a relatively consistent force vector over this expandedabduction range. The force vector decreases at the center of an expandedrange created by the loop defined by the cable 46 and connection member48 when the lower pulley assembly 20 and the upper pulley assembly 22are fixed. For example, an abduction range of about 60 degrees can splitinto at least two ranges of about 30 degrees by movement of the lowerpulley assembly 20 and the upper pulley assembly 22.

Referring now to FIG. 8, the lower beam 12 is attached to the surgicaltable 102 by the locked clamp assembly 18. In particular, semi-lockedclamp assembly 18 is attached to an accessory rail 101 of the surgicaltable 102. The semi-locked clamp assembly 18 allows for adjustments toarm flexion angle during lateral decubitus shoulder procedures. Whenadjustments are desired, the lower rod 12 may pivot to rotate the frame10 to allow for changes in arm flexion. When the frame 10 rotates, thepulley swingers 32 of the lower and upper pulley assemblies 20 and 22allow the pulleys 30 a and 30 g to swing in response. This swingingprevents strain on the pulleys 30 a and 30 g and keeps traction forceson a patient's arm relatively consistent throughout rotation of frame10.

The semi-locked clamp assembly 18 shown in FIGS. 8-10 includes a hook200 extending downwardly from an interior of lower rod 12. The hook 200is inserted into a base sleeve 202 having a tube 204 protrudingtherefrom. The tube 204 is positioned in the interior of a clamp body206. An end of the tube 204 is engaged by a bottom collar 208 to retainthe tube 204 in the clamp body 206.

The tube 204 is engaged by a flange bearing 210 and a sleeve bearing 212which are both shown in FIGS. 9 and 10. The bottom collar 208 is ofsufficient diameter to prevent the sleeve bearing 212 from sliding offof the tube 204. Flange bearing 210 is in contact with a top block 214that is in contact with a press 216. The press 216 is in contact with aside bolt 218 that is threaded through clamp body 206 such that rotationof the side bolt 218 applies pressure to the press 216. Rotation of tube204 and, by extension, upper rod 14 relative to the clamp body 206 maybe semi-locked due to friction between the press 216 and the tube 204.“Semi-locked” as used herein, including in the claims, means capable ofmoving when adjusted by an operator but resisting movement such that theframe 10 does not rotate when the system 8 is in use with a patient. Theside bolt 218 is tuned to create a desired resistance to rotation oftube 204. In some embodiments, side bolt 218 is adjusted to create apredetermined resistance to rotation.

A brake 220 is located between the flange bearing 210 and the sleevebearing 212 and is in contact with a lock bolt 222 attached to a lockknob 224 as shown in FIG. 12. The lock bolt 222 is threaded throughclamp body 206 such that rotation of the lock knob 224 and thus, thelock bolt 222, applies pressure to the brake 220. Rotation of tube 204and, by extension, upper rod 14, relative to the clamp body 206 may belocked due to friction between the brake 220 and the tube 204.

The clamp body 206 is adapted to receive the flange bearing 210, thesleeve bearing 212, the top block 214, the press 216, the brake 220, andthe tube 204 such that movement of the tube 204 relative to the clampbody 206 is restricted to rotational movement. Clamp body 206 is fixedto a rail attachment 226. A rail bolt 228 attached to a rail knob 230 isthreaded within the clamp body 206 such that the rail bolt 228penetrates the rail attachment 226 and contacts the accessory rail 101of surgical table 102. Rotation of the rail knob 230 secures thesurgical arm positioning system 8 to the accessory rail 101 of surgicaltable 102.

Illustratively, movement of the tube 204 may be resisted by press 216 toan extent such that when a patient's arm is attached, the resistance issufficiently weak to be overcome by a clinician to change the positionof the tube 204 and by extension lower rod 12 and upper rod 14 relativeto the clamp body 206 and thus, adjust the patient's arm. Afteradjusting the arm, the resistance due to press 216 is sufficient thatthe tube 204 reaches a state of equilibrium and the patient's arm isheld in place.

In some embodiments, the frame 10 may be rotated by the handle 52 asshown in FIG. 1. In further embodiments, the frame 10 may be rotated bymoving the patient's arm directly. The surgical arm positioning system 8responds to movement of the patient's arm without direct contact fromits operator. Thus, a surgeon or surgeon's assistant does not need totouch the mechanical components of frame 10 that would result in a breakin the sterile field in order to reposition the patient's arm.

The combination of the rotation mechanism with the other adjustmentmechanisms described herein allows the overall arm abduction range ofthe surgical arm positioning system 8 to be expanded while keepingtraction forces relatively consistent throughout. This combinationallows the surgical arm positioning system 8 to respond to movement ofthe patient's arm without direct contact from its operator.

When not in use, the surgical arm positioning system 8 folds into a morecompact form. The internal pulley assembly 300, shown in FIG. 7, ispositioned in the interior of upper rod 14 and is configured to preventthe upper rod 14 from collapsing toward the lower rod 12, until theoperator pulls the handle 42. The internal pulley assembly 300 includesan internal pivot 302, a handle pin lever 304 connected to the handle42, a slot lifter 308, and the rear pulley mount 306. The internal pivot302 has three pairs of wheels 313 a, 313 b, and 313 c. Referring toFIGS. 7 and 13, wheels 313 a and 313 b are engaged by the rails 38 ofthe upper rod 14 and wheel 313 c is engaged by the rails 38 of the lowerrod 12, similar to the way that the lower and upper pulley assemblies 20and 22 are engaged by the rails 38. Still referring to FIG. 13, theinternal pivot 302 has a first latch 310 that engages a pin 44 of thelower rod 12 to prevent the internal pivot 302 from falling toward thelower rod 12. Additionally, the internal pivot 302 has a second latch314 engaged by the slot lifter 308 to prevent the upper rod 14 frommoving along wheels 313 a and 313 b relative to the internal pivot 302.As such, the internal pivot 302 holds the lower and upper rods 12 and 14at a fixed angle.

When the operator pulls the release handle 42 in the direction indicatedby arrow 312, the resulting motion moves the handle pin lever 304 andslot lifter 308 in a direction opposite arrow 312. The slot lifter 308has a guide slot 309 that receives a guide pin 311. As the slot lifter308 moves opposite arrow 312, it disengages from the second latch 314 ofthe internal pivot 302, freeing the upper rod 14 to move in thedirection of arrow 23, distal to the patient. Referring again to FIGS. 7and 13, as the upper rod 14 retracts, it eventually causes the internalpivot 302 to pivot about wheel 313 c, thus disengaging the first latch310 from the pin 44. The upper rod 14 can continue to retract and rotateinto a position substantially parallel to the lower rod 12. When thelower and upper rods 12 and 14 are substantially parallel, the system 8is in a folded position for transport and storage.

Referring again to FIG. 1, in a second embodiment of the instantdisclosure of the surgical arm positioning system 8, several componentsattached to frame 10 are substituted by functionally similar components.Starting at the connection member 48, the cable 46 is routed through apulley carriage 1220 (shown in FIGS. 45-47), an internal pivot 1302(shown in FIGS. 48 and 54), a clutch assembly 1300 (shown in FIGS. 48and 54), a weight assembly 1500 (shown in FIGS. 52 and 53), the internalpivot 1302 again, and another pulley carriage 1220, before returningback to the connection member 48 to form a loop.

In the second embodiment, the lower and upper pulley assemblies 20 and22 are each substituted by a pulley carriage 1220, as shown in FIGS.45-47. The pulley carriage 1220 includes a sled body 1226, lock knobs1236, a pulley 30 a, a pulley swinger 1232, and a plurality of wheels34. As shown in FIG. 47, the roller sled 1226 has an opening 1202, and abracket 1204 protrudes from the roller sled 1226 into the opening 1202.Four wheels 34 are attached to the bracket 1204 opposite two pins 1206,which define a first axis 1208. The pulley swinger 1232 has two arms1210, each having an aperture 1212. Each of the pins 1206 extendsthrough the aperture 1212 of one of the arms 1210 such that the pulleyswinger 1232 can pivot about the first axis 1208. The pulley 30 arotates about a second axis 1214 that is perpendicular to the axis 1208.When pulley swinger 1220 is used with the system 8, the cable 46 passesalong the pulley 30 a proximal to the sled body 1226. Referring to FIG.1, when the patient's arm is moved into or out of the plane of the planeof the surgical arm positioning system 8, such flexion or extension whenthe patient is on his or her side, the pulley swinger 1232 pivots aboutthe first axis 1208 in response.

Referring now to FIG. 48, two pulleys 30 b and 30 c are attached to theinternal pivot 1302. After passing through the pulley carriage 1220, thecable 46 passes along pulley 30 b, distal to the internal pivot 1302,before reaching the clutch assembly 1300. The clutch assembly 1300includes a rear pulley mount 1306 having a pulley 30 d and two clutchpulleys 40 a and 40 b attached thereto. The cable 46 passes along clutchpulley 40 a, proximal to pulley 30 d, and continues to the weightassembly 1500.

Referring now to FIGS. 52 and 53, the weight assembly 1500 includes aplurality of detachable weights 1502, a tether 1504, and a pulleyhousing 1506. The pulley housing 1506 houses two pulleys 30 f and 30 f(shown in FIG. 53 with part of pulley housing 1506 omitted). The pulleys30 f and 30 f are sufficiently separated from each other that cable 46does not twist when the system 8 is in use with a patient. Referring toFIG. 53, the pulley housing 1506 surrounds the pulleys 30 f and 30 f′ toavoid displacement of the cable 46 wrapped around the pulleys 30 f and30 f. The pulley housing 1506 is coupled to the tether 1504, which isadapted to receive detachable weights 1502 thereon. The detachableweights 1502 each have a substantially frustoconical shape to facilitatestacking several weights on a base 1510 of the tether 1504. Referringagain to FIG. 52, the detachable weights 1502 also each have a gap 1508therein. The gap 1508 is wider than the width of the tether 1504 suchthat an operator can elevate the detachable weights 1502 toward thepulley housing 1506 and pull the detachable weights 1502 off of theweight assembly 1500 by passing the tether 1504 through the gap 1508.The operator can add or removing detachable weights 1502 depending onthe amount of force to be applied to the cable 46.

The cable 46 passes along pulleys 30 f and 30 f′, proximal to thedetachable weights 1502, before returning to the rear pulley mount 1306to pass along clutch pulley 40 b, distal to clutch pulley 40 a, as shownin FIG. 48. In some embodiments, the cable 46 may wrap around one orboth of the clutch pulleys 40 a and 40 b one time or multiple times,such as two, three, or four times. Embodiments having cable 46 onlypartially wrapped (e.g., less than) 360° around one or more of pulleys30, 40 is also within the scope of this disclosure. After passing along,and possibly wrapping around, the clutch pulleys 40 a and 40 b, thecable 46 passes along pulley 30 d, proximal to 40 a and continues to thepulley carriage 1220 on the upper rod 14. After passing along pulley 30a of the pulley carriage 1220 on the upper rod 12, proximal to the sledbody 1226, the cable 46 reaches the connection member 48.

One skilled in the art will appreciate that the surgical arm positioningsystem may include any number of internal clutch pulleys 40 and freepulleys 30 capable of restricting movement of cable 46 to a desiredextent. Thus, in some embodiments, more than one internal clutch pulley40 is used. In other embodiments, free pulleys 30 may be used withoutthe use of an internal clutch pulley 40.

Referring again to FIG. 46, one pulley carriage 1220 is connected to thelower rod 12 and another pulley carriage 1220 is connected to the upperrod 14. The pulley carriages are linked by a two connecting rods 1224such that movement of one of the pulley carriages 1220 results inmovement of the other. The connecting rods 1224 maintain a consistentdistance between pulley carriages 1220 as they move along respectiverods 12 and 14. The connecting rods 1224 are connected to the pulleycarriages 1220 by pins (not shown) that extend through apertures 1222 inthe sled bodies 1226 of the pulley carriages 1220, as shown in FIG. 46.As the pulley carriages 1220 are moved along the frame 10, theconnecting rods 1224 pivot about the apertures 1222 of pulley carriages1220. The rails 38 of lower rod 12 interact with one of the pulleycarriages 1220 such that the wheels 34 are held within lower rod 12 bythe rails 38 and the pulley carriage 1220 can move along the length oflower rod 12. Similarly, the rails 38 of upper rod 14 interact with theother pulley carriage 1220 such that the wheels 34 are held within upperrod 14 by the rails 38 and the pulley carriage 1220 can move along thelength of upper rod 14.

As shown in FIGS. 45-47, the pulley carriages 1220 have lock knobs 1236that have a threaded portion 1237 extending through holes 1239 and 1243of the sled body 1226. The lock knobs 1236 can be rotated by theoperator in one direction to lock one or both of the pulley carriages1220 in place relative to the lower and upper rods 12 and 14 and can berotated in an opposite direction to release the pulley carriages 1220.When pulley carriages 1220 are used instead of lower and upper pulleyassemblies 20, 22, the pulley carriages 1220 can be locked in place byadjusting lock knobs 1236 after the patient's arm has been positioned.

In the second embodiment, the semi-locked clamp assembly 18 issubstituted by a modified clamp assembly 1400. As shown in FIG. 49, themodified clamp assembly 1400 includes a rod bracket 1452, a clamp bodyassembly 1454, and a lever assembly 1456. The rod bracket 1452 is fixedto the lower rod 12 and the lever assembly 1456 is coupled to the rodbracket 1452 for transmitting rotational motion thereto. The clamp bodyassembly 1554 is configured to clamp to the rail 101 of a surgical table102 and thus mount the system 8 top the surgical table 102.

Referring to FIGS. 49-51, the clamp body assembly 1454 includes amounting plate 1460, a housing 1462, and two bolts 1464. As best seen inFIG. 49, when the clamp body assembly 1454 is clamped to the rail 101 ofsurgical table 102, the mounting plate 1460 interfaces the rail 101 andthe housing 1462 surrounds the mounting plate 1460 and the rail 101 tohold the mounting plate 1460 to the rail 101. The bolts 1464 extendthrough apertures 1466 in the mounting plate 1460 and push against afront surface 103 of the rail 101. As the bolts 1464 further pushagainst front the surface 103 of the rail 101, the housing 1462experiences a corresponding force against a back surface 105 of the rail101, thus securing the clamp body assembly 1454 to the rail 101.

Referring again to FIGS. 50 and 51, the lever assembly 1456 includes alever 1470 coupled to a longitudinal tube 1472 by an arm 1474. Acogwheel 1468 has a plurality of cogs 1476 and is fixed to the housing1462 (shown in FIG. 49). The tube 1472 is surrounded by a lower bearing1478 and a flange bearing 1480, which reside in a cylindrical cavity(not shown) of the housing 1462. The arm 1474 and lever 1470 are coupledto the tube 1472 such that movement of the lever 1470 along the cogwheel1468 causes the longitudinal tube 1474 to rotate about an axis 1482within the housing 1462. The lever 1470 pivots relative to the arm 1474and includes a pin 1484 for engaging the cogwheel 1468 to block rotationof the tube 1472. The rod bracket 1452 is attached to the tube 1472opposite the lower bearing 1478.

The modified clamp assembly 1400 can be used by the operator to rotatethe frame 10 of the surgical arm positioning system 8. Still referringto FIGS. 49-51, the lever 1470 is shown in an engaged position forblocking rotation of the frame 10. When the lever 1470 is pulled awayfrom the surgical table 102, the pin 1484 disengages from the cogwheel1468 and no longer blocks the tube 1472 from rotating. By moving thedisengaged lever 1470 about axis 1482, the tube 1472, and by extensionthe rod bracket 1452 and the frame 10, are rotated about axis 1482.Rotation of the frame 10 about the axis 1482 causes changes in flexionangle when the system 8 is in use with a patient. Once the frame 10reaches a desired position, the lever 1470 can be pushed toward thesurgical table 102 to engage the pin 1484 in the cogwheel 1468 and lockrotation of the frame 10.

In the second embodiment, the internal pulley assembly 300 issubstituted by a modified internal pulley assembly 1300, as shown inFIG. 48. The internal pulley assembly 1300, as shown in FIG. 48, ispositioned in the interior of upper rod 14 and is configured to preventthe upper rod 14 from collapsing toward the lower rod 12, until theoperator pulls the handle 1342. The internal pulley assembly 1300includes an internal pivot 1302, a handle pin lever 1304 connected tothe handle 1342, a slot lifter 1308, and the rear pulley mount 1306. Theinternal pivot 1302 has two pairs of wheels 1313 a and 1313 b, a notch1315, an aperture 1317, and a stud 1320 (shown in FIG. 54). The wheels1313 a and 1313 b are engaged by the rails 38 of the upper rod 14similar to the way that the lower and upper pulley assemblies 20 and 22are engaged by the rails 38. As shown in FIG. 54, a first pin 1316extends through lower rod 12 and aperture 1317 to couple the internalpivot 1302 to the lower rod 12. A second pin 1318 extends through thelower rod 12 above pin 1316 and is engaged by notch 1315 to prevent theupper rod 14 from falling toward the patient. Additionally, the stud1320 has an aperture 1321 therein and is attached to the internal pivot1302 by a pin 1324. The stud 1320 can rotate and rest against a bracket1322 that is attached to the lower rod 12 to prevent the upper rod 14from falling away from the patient. As such, the internal pivot 1302holds the lower and upper rods 12 and 14 at a fixed angle.

Referring again to FIG. 48, when the operator pulls the release handle1342 in the direction indicated by arrow 312, the resulting motion movesthe handle pin lever 1304 and slot lifter 1308 in a direction oppositearrow 312. The handle pin lever 1304 has a guide slot 1309 that receivestwo guide pins 1311. As the slot lifter 1308 moves, it disengages fromthe notch 1315 of the internal pivot 1302, freeing the upper rod 14 tomove in the direction of arrow 23, distal to the patient. Referringagain to FIG. 54, as the upper rod 14 retracts, it eventually causes thestud 1320 to disengage from the bracket 1322, thus allowing the internalpivot 1302 to pivot about the pin 1316. In the second embodiment, thelower rod 14 has a gap 1326 therein, which the internal pivot 1302partly passes through while pivoting. The upper rod 14 can continue toretract and rotate into a position substantially parallel to the lowerrod 12. When the lower and upper rods 12 and 14 are substantiallyparallel, the system 8 is in a folded position for transport andstorage.

Referring now to FIG. 61, in a third embodiment of the instantdisclosure of the surgical arm positioning system 8, several componentsattached to frame 10 are substituted by functionally similar components.In a third embodiment of the instant disclosure of the surgical armpositioning system 8, starting at the connection member 48, the cable 46is routed through a pulley carriage 2220, an internal pivot 2302, aclutch assembly 2300, a weight assembly 1500, the internal pivot 2302again, and another pulley carriage 2220, before returning back to theconnection member 48 to form a loop.

In the third embodiment, the lower and upper pulley assemblies 20 and 22are each substituted by a pulley carriage 2220, as shown in FIGS. 62 and63. The pulley carriage 2220 includes a sled body 2226, a pulley 30 a, apulley swinger 2232, and a plurality of wheels 34. The roller sled 2226has an opening 2202, and a bracket 2204 protrudes from the roller sled2226 into the opening 2202. Two of the wheels 34 are attached to thebracket 2204 opposite two pins 2206, which define a first axis 2208. Thepulley swinger 2232 has two arms 2210, each having an aperture 2212.Each of the pins 2206 extends through the aperture 2212 of one of thearms 2210 such that the pulley swinger 2232 can pivot about the firstaxis 2208. The pulley 30 a rotates about a second axis 2214 that isperpendicular to the first axis 2208. Referring to FIG. 61, when pulleycarriage 2220 is used with the system 8, the cable 46 passes along thepulley 30 a proximal to the sled body 2226. When the patient's arm ismoved into or out of the plane of the surgical arm positioning system 8,such flexion or extension when the patient is on his or her side, thepulley swinger 2232 pivots about the first axis 2208 in response.

Referring now to FIGS. 67A and 67B two pulleys 30 b and 30 c areattached to the internal pivot 2302. After passing through the pulleycarriage 2220, the cable 46 passes along pulley 30 b, proximal to pulley30 b, before reaching the clutch assembly 2300. Referring now to FIG.68, the clutch assembly 2300 includes a rear pulley plate 2306 havingthree pulleys 30 d, 30 e, and 30 e′ and a clutch pulley 40 attachedthereto. Pulley 30 e′ is mounted to a spring loaded pivot 2303 that ismounted to the rear pulley plate 2306 by a pin 2305. The spring loadedpivot 2303 is biased to resist rotating about the pin 2303 toward ablock pin 2307. The block pin 2307 limits the range of rotation of thespring loaded pivot 2303. The cable 46 passes along pulley 30 d, distalto the clutch pulley 40, and continues to the weight assembly 1500.Referring again to FIGS. 52 and 53, the cable 46 passes along pulleys 30f and 30 f′, proximal to the detachable weights 1502, before returningto the rear pulley plate 2306. The cable 46 next passes along pulley 30e distal to pulley 30 e′, before passing along pulley 30 e′ distal tothe pin 2305. Next, the cable passes along clutch pulley 40, wrappingaround clutch pulley 40 one time. In some embodiments, the cable 46 maywrap around the clutch pulley 40 multiples times, such as two, three, orfour times. Embodiments having cable 46 only partially wrapped (e.g.,less than 360°) around one or more of pulleys 30 and 40 is also withinthe scope of this disclosure. Referring now to FIG. 67, after wrappingaround the clutch pulley 40, the cable 46 continues to pulley 30 c,above pulley 30 b, and continues to the pulley carriage 2220 on theupper rod 14. After passing along pulley 30 a, proximal to the sled body1226, the cable 46 reaches the connection member 48.

One skilled in the art will appreciate that the surgical arm positioningsystem may include any number of internal clutch pulleys 40 and freepulleys 30 capable of restricting movement of cable 46 to a desiredextent. Thus, in some embodiments, more than one internal clutch pulley40 is used. In other embodiments, free pulleys 30 may be used withoutthe use of an internal clutch pulley 40.

Referring now to FIGS. 62 and 64, one pulley carriage 2220 is connectedto the lower rod 12 and another pulley carriage 2220 is connected to theupper rod 14. The pulley carriages are linked by a two connecting rods2224 such that movement of one of the pulley carriages 2220 results inmovement of the other. The connecting rods 2224 maintain a consistentdistance between pulley carriages 2220 as they move along respectiverods 12 and 14. The connecting rods 2224 are connected to the pulleycarriages 2220 by pins 2240 that extend through a bearing 2242 and anaperture 2225 in each connecting rod 2224 to attach the connecting rod2224 to the pulley carriages 2220. As the pulley carriages 2220 aremoved along the frame 10, the connecting rods 2224 pivot about theapertures 2225 of pulley carriages 2220. The rails 38 of lower rod 12interact with one of the pulley carriages 2220 such that the wheels 34are held within lower rod 12 by the rails 38 and the pulley carriage2220 can move along the length of lower rod 12. Similarly, the rails 38of upper rod 14 interact with the other pulley carriage 2220 such thatthe wheels 34 are held within upper rod 14 by the rails 38 and thepulley carriage 2220 can move along the length of upper rod 14.

As shown in FIGS. 63 and 64, the pulley carriage 2220 coupled to thelower rod 12 includes a handle assembly 2250. The handle assembly 2250includes a U-shaped handle bracket 2252, two handles 2254, and a blockarm 2256. The handle bracket 2252 is mounted to the sled body 2226 ofthe pulley carriage 2220 by bolts 2258 that extend through apertures2260 of the handle bracket 2252 into the sled body 2226. The handlebracket 2252 and the sled body 2226 define an opening 2262 sized tosurround that lower rod 12, as shown in FIG. 64. The block arm 2256 isattached to the handle bracket 2252 opposite the pulley carriage 2220and extends parallel to the sled body 2226 into a block head 2264. Theblock arm 2256 is mounted to the handle bracket 2252 by a bolt 2266 thatextends through an aperture 2268 in the block arm 2256. The handles 2254are attached to the block arm 2256.

The handle assembly 2250 is configured for an operator to grasp one ofthe handles 2254 to move the pulley carriages 2220 along the frame 10.Referring again to FIG. 63, the handle assembly 2250 includes a pin 2270that extends into the opening 2262. A plurality of clips 2280 areattached to the lower rod 12, as shown in FIG. 67A. The clips 2280 eachhave a wedge 2282 that can engage the pin 2270 to hold the handleassembly 2250 and pulley carriage 2220 stationary relative to the lowerrod 12 when the system 8 is in use for surgery. Depending on the desiredposition of the pulley carriages 2220, the operator can apply sufficientforce to the handle 2254 to disengage the pin 2270 from one of the clips2280 and use the handle 2254 to move the handle assembly 2250 and pulleycarriage 2220 along the lower rod 12 until the pin 2270 engages anotherone of the clips 2280.

In the third embodiment, the semi-locked clamp assembly 18 issubstituted by a modified clamp assembly 2400. As shown in FIGS. 65 and66, the modified clamp assembly 2400 includes a rod bracket 2452, aclamp body assembly 2454, and a lever assembly 2456. The rod bracket2452 is secured to the lower rod 12 and the lever assembly 2456 iscoupled to the rod bracket 2452 for transmitting rotational motionthereto. The clamp body assembly 2554 is configured to clamp to the rail101 of surgical table 102 and thus mount the system 8 top surgical table102.

Still referring to FIGS. 65 and 66, the clamp body assembly 2454includes a mounting plate 2460, a housing 2462, two bolts 2464, and twopress blocks 2465. When the clamp body assembly 2454 is clamped to therail 101 of surgical table 102, the mounting plate 2460 interfaces therail 101 and the housing 2462 surrounds the mounting plate 2460 and therail 101 to hold the mounting plate 2460 to the rail 101. The bolts 2464extend through apertures 2466 in the press blocks 2465, which aresecured to the housing 2462 by two screws 2467. The press blocks 2465are disposed against a front surface 103 of the rail 101. As the bolts2460 further push the press blocks 2465 against front the surface 103 ofthe rail 101, the housing 2462 experiences a corresponding force againsta back surface 105 of the rail 101, thus securing the clamp bodyassembly 2454 to the rail.

Referring to FIG. 66, the lever assembly 2456 includes a cogwheel 2468and a lever 2470 coupled to a longitudinal tube 2472 by an arm 2474. Thecogwheel 2468 has a plurality of cogs 2476 and is fixed to the housing2462. The tube 2472 is surrounded by a flange bearing 2480, whichresides in a cylindrical cavity (not shown) of the housing 2462. The arm2474 and lever 2470 are coupled to the tube 2472 such that movement ofthe lever 2470 along the cogwheel 2468 causes the longitudinal tube 2472to rotate about an axis 2482 within the housing 2462. The lever 2470pivots relative to the arm 2474 and includes a pin 2484 for engaging thecogwheel 2468 to block rotation of the tube 2472. The rod bracket 2452attaches the lower rod 12 to the tube 1472 opposite the lower bearing2478.

The modified clamp assembly 2400 can be used by the operator to rotatethe frame 10 of the surgical arm positioning system 8. Referring againto FIGS. 65 and 66, the lever 2470 is shown in an engaged position forblocking rotation of the frame 10. When the lever 2470 is pulled awayfrom the surgical table 102, the pin 2484 disengages from the cogwheel2468 and no longer blocks the tube 2472 from rotating. By moving thedisengaged lever 2470 about axis 2482, the tube 2472, and by extensionthe rod bracket 2452 and the frame 10, are rotated about axis 2482.Rotation of the frame 10 about the axis 2482 causes changes in flexionangle when the system 8 is in use with a patient. Once the frame 10reaches a desired position, the lever 2470 can be pushed toward thesurgical table 102 to engage the pin 2484 in the cogwheel 2468 to lockrotation of the frame 10.

In the third embodiment, the internal pulley assembly 300 is substitutedby a modified internal pulley assembly 2300, as shown in FIGS. 68 and69. The internal pulley assembly 2300 is attached to the end of upperrod 14 and is configured to prevent the upper rod 14 from collapsingtoward the lower rod 12, until the operator pulls the handle 2342. Theinternal pulley assembly 2300 includes an internal pivot 2302 (shown inFIGS. 67A and 67B), two handle levers 2304 connected to the handle 2342,an arm 2350, and the rear pulley plate 2306. Referring to FIG. 67B, theinternal pivot 2302 has two pairs of wheels 2313 a and 1313 b, a wedge2315, an aperture 2317, and a stud 2320. The wheels 2313 a and 2313 bare engaged by the rails 38 of the upper rod 14 similar to the way thatthe lower and upper pulley assemblies 20 and 22 are engaged by the rails38. A first pin 2316 extends through lower rod 12 and aperture 2317 tocouple the internal pivot 1302 to the lower rod 12. A second pin 2318extends through the lower rod 12 above pin 2316 and is engaged by wedge2315 to prevent the upper rod 14 from falling toward the patient.Additionally, the stud 2320 has an aperture 2321 therein and is attachedto the internal pivot 3302 by a pin 2324. The stud 2320 can rotate andrest against a bracket 2322 attached to the lower rod 12 to prevent theupper rod 14 from falling away from the patient. As such, the internalpivot 2302 holds the lower and upper rods 12 and 14 at a fixed angle.

Referring again to FIGS. 67A and 69, when the operator pulls the releasehandle 2342 in the direction indicated by arrow 312, the resultingmotion moves the handle levers 2304, including a crossbar 2358 thatextends between the handle levers 2304, in a direction opposite arrow312. The arm 2350 is attached between the handle levers 2304 by two pins2352 and two bearings 2354 such that the arm 2350 can rotate about anaxis 2356. The arm 2350 has a wedge 2315 positioned opposed the handle2342 that engages a notch 2314 of the internal pivot 2302. As thecrossbar 2358 moves opposite arrow 312, it pushes the wedge 2315 out ofthe notch 2314, freeing the upper rod 14 to move in the direction ofarrow 23, distal to the patient. As the upper rod 14 retracts, iteventually causes the stud 2320 to disengage from the bracket 2322, thusallowing the internal pivot 2302 to pivot about pin 2316, as shown inFIG. 67B. In the third embodiment, the lower rod 14 has a gap 2326therein, which the internal pivot 2302 partly passes through whilepivoting.

Referring now to FIGS. 70 and 71, the upper rod 14 can continue toretract into a position substantially parallel to the lower rod 12. Whenthe lower and upper rods 12 and 14 are substantially parallel, thesystem 8 is in a folded position for transport and storage. In thefolded position, the upper rod 14 is held within a mount 2370 attachedto the lower rod. The mount 2370 has an opening (not shown) thatreceives a spring-loaded pin 2374 attached to a housing 2376 that coversthe internal pulley assembly 2300 to hold the frame 10 in the foldedposition. Additionally, an upper block 2380 is attached to the upper rod14. In the folded position, the upper block 2380 rests against the blockhead 2264 of the handle assembly 2250 to prevent the housing 2376 fromcontacting the lower rod 12. A handle 2382 is attached to the lower rod12 to facilitate transport of the folded system 8. The operator may pullthe spring-loaded pin 2374 to release the frame 10 from the foldedposition and reposition upper rod 14 to prepare the system 8 for usewith a patient.

Referring now to FIG. 1, in some embodiments, the upper rod 14 of thesurgical arm positioning system 8 receives shoulder distractionapparatus 400 for applying a lateral distraction force to the patient'sarm. The shoulder distraction apparatus 400 and the lateral tractionstrap 500, which is attached to the shoulder distraction apparatus,allow a physician to apply lateral traction force to a patient's armthroughout a range of positions during shoulder arthroscopy whilemaintaining sterility. When a physician or other sterile staff adjust apatient's sterile arm, the shoulder distraction apparatus 400 respondsto such adjustments without requiring the operator to touch non-sterilecomponents. As such, the shoulder distraction apparatus 400 does notrequire assistance from a non-sterile staff member.

The shoulder distraction apparatus 400 provides for several methods ofadjustability and several directions of adjustability. Referring to FIG.14, the extension bar 400 can extend and retract in the direction ofarrow 401 and can rotate about axis 403. Braking mechanisms between theextension bar 400 and the upper rod 14 may be included with the system 8to control the ease of extension, retraction, and rotation of extensionbar 400. Additionally, the operator can adjust sterile strap 500, whichis shown in FIGS. 18 and 19, to adjust the lateral traction forceprovided by sterile strap 500 to the patient's arm without touchingnonsterile components. Intraoperative control of the adjustmentsdescribed herein provides quicker, more accurate positioning compared tosystems and methods known in the art.

Easy adjustment of extension and retraction of the extension bar 400,along with the extension bar 400 providing sufficient length, allows forlateral traction to be pulled superior to the patient's shoulder withouta member of the sterile staff pushing on the patient's arm to achievesuperior displacement of the humeral head. Rotation of the extension bar400 about axis 403 allows for adjusting anterior and posterior tractionvectors without a member of the sterile staff pressing on the patient'sshoulder. Such adjustments may be desirable in lateral shoulderarthroscopy.

The shoulder distraction apparatus 400 includes a mast 402 connectableto a surgical arm positioning system 8 as shown in FIGS. 14 and 15.Illustratively, the mast 402 is connectable to the upper rod 14. Themast 402 is attached to a platform 404.

The platform 404 is configured to engage a rotation stud 406, as shownin FIG. 16. The rotation stud 406 is surrounded by a washer 408 and isattached to an angled bracket 410, shown in FIG. 17. The angled bracket410 may rotate relative to the platform 404, resulting in movement ofcomponents attached to the angled bracket 410, discussed hereinbelow.

The angled bracket 410 is attached to a pair of wheels 412. The wheels412 are engaged by rails 414 of a lateral beam 416 such that the lateralbeam 416 may be moved relative to the angled bracket 410, the platform404, and the mast 402.

The lateral beam 416 is attached to a pivot connector 418 that ispivotably attached to a pivot member 420. The pivot member 420 ispivotably attached to the pivot connector 418 by a pivot pin 422. Thepivot member 420 has a hook pin 424 capable of detachably receiving ahook 426. In some embodiments, the hook 426 is pivotably attachable tothe hook pin 424 of the pivot member 420. Illustratively, the pivotmember 420 may pivot relative to the pivot connector 418 in a directionperpendicular to the pivoting of the hook 426 relative to the pivotconnector 418. Pivoting of the pivot member 420 and the hook 426 allowthe shoulder distraction apparatus 400 to respond to adjustment of thepatient's arm without itself needing additional adjustment.

The hook 426 is attached to a tension meter 428 having a first end 430and a second end 432. The hook 426 is attached to the second end 432 ofthe tension meter 428. A hook lock 434 for locking the hook 426 to thehook pin 424 of the pivot member 420 is also attached to the second end432 of the tension meter 428. The first end 430 of the tension meter 428has a hanger 436 capable of receiving a lateral distractor strap 500.When the lateral distractor strap 500 is attached to the hanger 436 andtension is applied to a patient's arm by the lateral distractor strap500, the tension meter 428 provides a physician information indicatingthe amount of traction applied to the patient's arm.

In some embodiments, the tension meter 428 is surrounded by a hangerflange 438 for separating sterilized components from non-sterilizedcomponents. One skilled in the art will appreciate that the hangerflange 438 may be attached to the shoulder distraction apparatus 400 inany manner that separates sterilized components from non-sterilizedcomponents and alternative configurations are within the scope of thisdisclosure.

When the shoulder distraction apparatus 400 is not in use for surgery,components of the shoulder distraction apparatus 400 may be sterilized.The hanger 436, the tension meter 428, the hanger flange 438, the hook426, and the hook lock 434 form a detachable assembly 440 and may bedetached from other components and sterilized. The use of the detachableassembly 440 provides the benefit of allowing individual components tobe sterilized. Also, the detachable assembly 440 may be easily attachedto the rest of the shoulder distraction apparatus 400 by a sterilephysician while maintaining sterility without the assistance ofnon-sterile personnel.

The lateral beam 416 is adjusted relative to the angled bracket 410 toadjust the position of the hanger 436 to account for factors such as thelength of the patient's arm, the position of the patient's arm, or thepatient's position on the surgical table. The position of the hanger 436may also be adjusted by rotation of the angled bracket 410 relative tothe platform 404. The position of the hanger 436 may further be adjustedby one or both of pivoting of the hook 426 about the hook pin 424 andpivoting the pivot member 420 about the pivot pin 422. The shoulderdistraction apparatus 400 provides the benefit of allowing for severalmethods of adjustability, thereby allowing the physician to control theposition of the hanger 436.

Referring now to FIG. 38, in the second embodiment, the shoulderdistraction apparatus 400 is substituted by a shoulder distractionapparatus 1400 that includes an extension bar 1000, a wheel bracket1002, a platform 1004, a brake foot 1006, a link 1024, and a lateraldistractor strap 500. The platform 1004 supports the wheel bracket 1002and is attached to a first end region 1008 of the upper rod 14. Itshould be appreciated that the platform 1004 may be attached to othercomponents of the surgical arm positioning system 8 or may be supportedby an assembly other than the surgical arm positioning system 8. Forexample, the platform 1004 may be attached to a post that is attached tothe surgical table in some embodiments. The wheel bracket 1002 iscoupled to the extension bar 1000 such that the extension bar 1000extends and retracts relative to the upper rod 14 as shown in FIGS. 42Aand 42B.

The link 1024 is attached to a first end 1010 of the extension bar 1000,and the lateral distractor strap 500 hangs downwardly from the link1024. The link 1024 is configured to pivot about the first end 1010 ofthe extension bar 1000 toward and away from the wheel bracket 1002. Thelateral distractor strap 500 is adapted to receive a patient's aim suchthat a lateral distraction force is applied to the patient's arm and acorresponding downward force is applied to the first end 1010 of theextension bar 1000 in the direction indicated by arrow 1026 in FIG. 38.The extension bar 1000, the wheel bracket 1002, the platform 1004, andthe brake foot 1006 illustratively comprise stainless steel, but in someembodiments may alternatively or additionally comprise other materials.Suitable materials include, but are not limited to, other metals such asaluminum, iron, or metal alloys; or plastics such as polypropylene.

The extension bar 1000 has an outer lower surface 1120, an outer uppersurface 1122 opposite the outer lower surface 1120, and an I-shapedcross section to provide tracks 1012 on opposite sides of the extensionbar 1000 as shown in FIGS. 38 and 39. Each track 1012 has asubstantially vertical inner surface 1014, a top surface 1016, and abottom surface 1018. The top and bottom surfaces 1016, 1018 aresubstantially parallel to each other along the length of the extensionbar 1000 and are substantially perpendicular to inner surface 1014. Theinner, top, and bottom surfaces 1014, 1016, 1018 of each track 1012define a wheel-receiving gap 1021. The extension bar 1000 has first stopsurfaces 1022 and second stop surfaces 1023 (see FIGS. 42A, 42B, and 43)at opposite ends of the extension bar 1000.

The wheel bracket 1002 has a body 1030 and two arms 1032 as shown inFIGS. 40 and 41. The body 1030 has a top face 1034, a bottom face (notshown) opposite the top face 1034, a front side 1036, a back side 1038opposite the front side 1036, a left side 1056, and a right side 1058opposite the left side 1056 as shown in FIG. 40. The left and rightsides 1056, 1058 connect the front and back sides 1036, 1038. A hole1040 extends through the body 1030 from the top face 1034 to the bottomface. The center of the hole defines a first rotational axis, indicatedby broken line 1042 as shown in FIG. 40. The left side 1056 and theright side 1058 of the body 1030 each has one of the arms 1032 extendingtherefrom. The arms 1032 extend substantially parallel to each otherfrom the top face 1034 and the front side 1036 of the body 1030.

Each of the arms 1032 of the wheel bracket 1002 has an upper hole 1044,a lower hole 1046, a front side 1048, a back side 1050, and a topsurface 1052. The front and back sides 1048, 1050 extend away from thebody 1030 of the wheel bracket 1002 to the top surface 1052. The topsurface 1052 has substantially semicircular curvature in theillustrative example. The arms 1032 mirror each other in structure,forming two parallel planes defining a gap 1054 therebetween as shown inFIG. 41. The gap 1054 is sized to receive the extension bar 1000.

The centers of the upper holes 1044 of the arms 1032 define a secondrotational axis, indicated by broken line 1060 in FIG. 41. The secondrotational axis 1060 is perpendicular to the first rotational axis 1042.The upper holes 1044 are located in the arms 1032 such that the secondaxis 1060 is closer to the front side 1036 than the back side 1038 ofthe body 1030 and the second axis 1060 does not intersect the first axis1042. The centers of the lower holes 1046 define a third rotationalaxis, indicated by broken line 1062. The third rotational axis 1062 isperpendicular to the first rotational axis 1042 and parallel to thesecond rotational axis 1060. The lower holes 1046 are located in thearms 1032 such that the distance between the third axis 1062 and thefront side 1048 of each arm 1032 is shorter than the distance betweenthe second axis 1060 and the front side 1048 of each arm 1032.Additionally, the distance between the third axis 1062 and the top face1034 of the body 1030 is shorter than the distance between the secondaxis 1060 and the top face 1034 of the body 1030.

The wheel bracket 1002 has two wheels 1064 mounted thereto as shown inFIG. 39. An axel 1066 is coupled to each wheel 1064. Each of the upperholes 1044 of the arms 1032 of the wheel bracket 1002 receives arespective one of the axels 1066 such that the wheels 1064 are coupledto opposite sides of the wheel bracket 1002 and coaxially rotate aboutthe second axis 1060. The wheels 1064 extend into the gap 1054 of thewheel bracket 1002 and inner annular surfaces 1063 of the wheels 1064face each other. The wheels 1064 are engaged by opposite tracks 1012 andreside within the wheel-receiving gaps 1020 of the extension bar 1000.

The distance between the inner annular surfaces 1063 of the wheels 1064is slightly larger than the distance between the inner surfaces 1014 ofopposite tracks 1012 of the extension bar 1000 so that the wheels 1064can rotate without interference from surfaces 1014. The spacing betweenthe wheels 1064 is sufficiently small such that the wheels 1064 preventmore than a slight amount of lateral shifting of the extension bar 1000relative to the wheel bracket 1002 in a direction perpendicular to theinner surfaces 1014 of the tracks 1012. In the illustrative embodiment,each wheel has an annular flange 1065 which serves as a thrust bearingbetween edges 1013 of tracks 1012 and the respective arm 1032 as shownin FIG. 39. It should be appreciated that, in some embodiments, onewheel 1064 and one track 1012 may couple the wheel bracket 1002 to theextension bar 1000. In further embodiments, the wheel 1064 may bereplaced by a sled, glide pad, or other mechanism capable of permittingtranslation of the extension bar 1000 relative to the bracket 1002.

The platform 1004 has a body 1070, upper and lower thrust washers 1072,1074, a bolt 1076, and a nut 1078 as shown in FIGS. 40 and 41. The body1070 has a curved outer surface 1079 that extends about 180°circumferentially around the platform 1004 and is centered at the firstrotation axis 1042. The body 1070 also has an internal passagewaytherein having a substantially cylindrical upper recess 1089 having afirst diameter, a substantially cylindrical lower recess 1090 having asecond diameter, and a substantially cylindrical cavity 1092 connectingthe recesses 1089, 1090 and having a third diameter as shown in FIG. 40.The upper recess 1089 is defined by an upper inner annular wall 1082having the first diameter and the lower recess 1090 is defined by alower annular wall 1084 having the second diameter. The cylindricalcavity 1092 is defined by a center inner annular wall 1080 having thethird diameter.

The inner annular walls 1080, 1082, 1084 are substantially cylindricaland are substantially parallel to each other. An upper shoulder surface1086 substantially perpendicular to the inner annular walls 1080, 1082,1084 connects the upper inner annular wall 1082 to the center innerannular wall 1080. A lower shoulder surface 1088 connects the lowerannular wall 1084 to the center inner annular wall 1080. In theillustrative embodiment, the first diameter is substantially the same asthe second diameter. In some embodiments, the platform 1004 comprises asubstantially cylindrical bronze bushing having a diameter slightlysmaller than the third diameter that resides within the cylindricalcavity 1092.

The upper and lower thrust washers 1072, 1074 each have an outer wallhaving an outer diameter and an inner wall having an inner diameter anddefining a hole therein. The outer diameter of the upper thrust washer1072 is slightly smaller than the first diameter of the upper recess1089 and larger than the third diameter of the cylindrical cavity 1092.The outer diameter of the lower thrust washer 1074 is slightly smallerthan the second diameter of the lower recess 1090 and larger than thethird diameter of the cylindrical cavity 1092. The upper and lowerthrust washers 1072, 1074 reside within the upper and lower recesses1089, 1090, respectively, and extend slightly above and below the body1070 of the platform 1004, respectively, as shown in FIG. 40. The bottomface of the body 1030 of the bracket 1002 rests against the upper thrustwasher 1072. The washers 1072, 1074 illustratively comprise bronze andare impregnated with oil.

The bolt 1076 has a head portion 1094 and a threaded portion 1096 havinga substantially cylindrical shape as shown in FIG. 40. The diameter ofthe threaded portion 1096 is slightly smaller than the inner diameter ofthe thrust washers 1072, 1074, and the head portion 1094 has a largerdiameter than the inner diameter of the upper thrust washer 1072. Thethreaded portion 1096 of the bolt 1076 extends through the hole 1040 ofthe wheel bracket 1002, the hole of the upper thrust washer 1072, andbeyond the hole of the lower thrust washer 1074 such that the headportion 1094 rests against the top face 1034 of the body 1030 of thebracket 1002 and the center of the threaded portion 1096 of the bolt1076 is substantially aligned with the first rotational axis 1042. Theresulting configuration allows the bracket 1002 and components coupledthereto, including the extension bar 1000, to rotate relative to theplatform 1004 about the first axis 1042. The nut 1078 is threaded ontothe threaded portion 1096 of the bolt 1076 to hold the bracket 1002 tothe platform 1002. In the illustrative embodiment, the nut 1078 may betightened or loosened along the threaded portion 1096 of the bolt 1076to adjust the ease at which the bracket 1002 rotates relative to theplatform 1004.

It is to be appreciated that other mechanisms to permit rotation of thebracket 1002 relative to the platform 1004 are contemplated by thisdisclosure. For example, the platform 1004 may comprise a bearing (e.g.,ball bearing or roller bearing) having portions that that can rotatewithin the body 1070 about the first axis 1042. The bracket 1002 may befixed to the bearing such that when the bearing rotates about the firstrotational axis 1042 within the body 1070, the wheel bracket 1002 alsorotates about the first rotation axis 1042. To adjust the ease at whichthe bracket 1002 rotates, a mechanism such as a clutch may be coupled tothe bracket 1002.

The body 1070 of the platform 1004 has a foot portion 1073 that extendsaway from the first axis 1042 and attaches to the first end region 1008of the upper rod 14 to mount the shoulder distraction apparatus 400 tothe rest of the surgical arm positioning system 8 as shown in FIGS. 38,40, and 41. The foot portion 1073 of the platform 1004 has a top wall1087, a left wall 1091, and a right wall 1093. The left wall 1088extends substantially parallel to the right wall 1093. The left wall1088 has two mounting holes 1095 therein as shown in FIG. 40. The footportion 1073 is coupled to the upper rod 14, which in some embodimentsis formed as an extrusion such that the foot portion 1073 fits therein.In the illustrative embodiment, the platform 1004 is bolted to the upperrod 14 by bolts that extend through holes in the first end region 1008of the upper rod 14 and into the mounting holes 1095 of the foot portion1073. It should be appreciated that the foot portion 1073 may have one,three, four, or more mounting holes 1095 in other embodiments.

The brake foot 1006 includes a body portion 1100 and a connectingportion 1102 as shown in FIG. 40. The brake foot 1006 also has a topsurface 1104, a back surface 1106, a front surface 1108, a left surface1110, and a right surface (not shown) opposite the left surface 1110.The top surface 1104 is oriented substantially perpendicular to the backsurface 1106, and the top and back surfaces 1104, 1106 are joined by theconnecting portion 1102. The connecting portion 1102 extends away fromthe back surface 1106, and a hole extends through the connecting portion1102 from the left surface 1110 to the right surface. The connectingportion 1102 resides in the gap 1054 of the wheel bracket 1002, and thehole of the brake foot 1006 is substantially aligned with the lowerholes 1046 of the wheel bracket 1002. A brake pin 1114 extends throughthe lower holes 1046 of the wheel bracket 1002 and through the hole ofthe brake foot 1006 to attach the brake foot 1006 to the wheel bracket1002 such that the brake foot 1006 can pivot relative to the wheelbracket 1002 about the third axis 1062.

The brake foot 1006 includes a horizontal brake 1116 and a verticalbrake 1118. The horizontal brake 1116 is positioned on the top surface1104 of the brake foot 1006, and the vertical brake 1118 is positionedon the back surface 1106 of the brake foot 1006 such that the verticalbrake 1118 is oriented substantially perpendicular to the horizontalbrake 1116. The horizontal brake 1116 is positioned under the outerlower surface 1120 of the extension bar 1000 and the vertical brake 1118is positioned over the curved outer surface 1079 of the platform 1004.In some embodiments, the brakes 1116, 1118 comprise a polymeric materialsuch as rubber. In other embodiments, one or both of the brakes 1116,1118 comprise metal.

The extension bar 1000 includes a magnetic catch 1130 as shown in FIG.43. The magnetic catch 1130 is positioned at a second end 1132 of theextension bar 1000 opposite the first end 1010 of the extension bar1000. The magnetic catch 1130 faces the upper rod 14 such that when thesecond end 1132 of the extension bar 1000 is in contact with the upperrod 14, the magnetic catch 1130 holds the extension bar 1000 against theupper rod 14.

The extension bar 1000 extends and retracts relative to the upper rod 14between an extended positioned and a retracted position. When theextension bar 1000 is in the retracted position, the wheels 1064 and thefirst stop surfaces 1022 are in contact such that the first stopsurfaces 1022 limit the range of retraction of the extension bar 1000relative to the upper rod 14 by preventing the extension bar 1000 fromfurther retracting as shown in FIG. 42A. In the retracted position, thecenter of mass of the extension bar 1000 is positioned behind the wheelbracket 1002 and over the upper rod 14 such that the second end 1132 ofthe extension bar 1000 falls toward the upper rod 14 when the weight ofthe second end 1132 is not supported. When the extension bar 1000 is inthe extended position, the wheels 1064 and the second stop surfaces 1023are in contact such that the second stop surfaces 1023 limit the rangeof extension of the extension bar 1000 relative to the upper rod 14 bypreventing the extension bar 1000 from further extending as shown inFIG. 42B.

The extension bar 1000 is movable relative to the wheel bracket alongthe direction of the inner surfaces 1014 of the tracks 1012. As theextension bar 1000 moves from the retracted position to the extendedposition, the wheels 1064 and the tracks 1012 guide movement of theextension bar 1000 relative to the upper rod 14 with the wheels 1064rotating about the second axis 1060 within the wheel-receiving gaps 1020of the tracks 1012 such that the first end 1010 of the extension bar1000 moves away from the wheel bracket 1002. As the extension bar 1000moves from the extended position to the retracted position, the wheels1064 and the tracks 1012 guide movement of the extension bar 1000relative to the upper rod 14 with the wheels 1064 rotating about thesecond axis within the wheel-receiving gaps 1020 of the tracks 1012 suchthat the first end 1010 of the extension bar 1000 moves toward the wheelbracket 1002. It should be appreciated that, in some embodiments, onewheel 1064 and one track 1012 may be used to guide movement of theextension bar 1000.

The extension bar 1000 is also moveable to a storage position as shownin FIG. 43. When the extension bar is in the storage position, thewheels 1064 and the first stop surfaces 1022 are in contact such thatthe first stop surfaces 1022 limit the range of retraction of theextension bar 1000 relative to the upper rod 14 by preventing theextension bar 1000 from further retracting, and the second end 1132 ofthe extension bar 1000 is sufficiently close to the upper rod 14 for themagnetic catch 1130 to interact with the material of the upper rod 14and hold the extension bar 1000 against the upper rod 14. The link 1024is shaped such that the wheel bracket 1002, the platform 1004, and thebrake foot 1006 can reside or partially reside therein. As the extensionbar 1000 moves from the retracted position to the storage position, thewheels 1064 remain substantially in place relative to the tracks 1012 ofthe extension bar 1000, such that the extension bar 1000 and wheels 1064rotate about the second axis 1060 causing the first end 1010 of theextension bar 1000 to move upwardly and the second end 1132 of theextension bar 1000 to move downwardly toward the upper rod 14.

As the extension bar 1000 moves from the storage position to theretracted position, the wheels 1064 remain substantially in placerelative to the tracks 1012 of the extension bar 1000, such that thatthe extension bar 1000 and wheels 1064 rotate about the second axis 1060causing the first end 1010 of the extension bar 1000 to move downwardlyand the second end 1132 of the extension bar 1000 to move upwardly awayfrom the upper rod 14. It should be appreciated that the upper rod 14may lack materials to which the magnetic catch 1130 is attracted, and areceiving piece comprising a material to which the magnetic catch 1130is attracted may be attached to the upper rod 14 for receiving themagnetic catch 1130. The magnetic catch 1130 allows the shoulderdistraction apparatus 400 to be easily stored and does not require anylocking mechanism to be manipulated prior to deploying the extension bar1000.

The extension bar 1000 is rotatable relative to the upper rod 14 betweena braked position and a released position. The designation of a brakedposition or a released position is independent of the designation of aretracted position or an extended position. For example, the extensionbar 1000 may be in a braked position or a released position when it isin an extended position, in a retracted position, or between theextended and retraction positions. When a patient's arm is supported bythe lateral distractor strap 500, the patient's arm causes the extensionbar 1000 to move into the braked position by applying a downward forcein the direction indicated by arrow 1026 in FIG. 38 to the first end1010 of the extension bar 1000. In the braked position, the brake foot1006 is positioned such that the horizontal brake 1116 is in contactwith the outer lower surface 1120 of the extension bar 1000 and thevertical brake 1118 is in contact with the curved outer surface 1079 ofthe platform 1004. In the braked position, friction between thehorizontal brake 1116 and the outer lower surface 1120 of the extensionbar 1000 prevents the extension bar 1000 from extending and retractingrelative to the wheel bracket 1002, the platform 1004, and the upper rod14. Also, friction between the vertical brake 1118 and the curved outersurface 1079 prevents the wheel bracket 1002 and the extension bar 1000from rotating relative to the platform 1004 and the upper rod 14 aboutaxis 1042.

When the lateral distractor strap 500 is not supporting the full weightof the patient's arm, the extension bar 1000 may be in a releasedposition. In the released position, as shown in FIGS. 42A and 42B, thebrake foot 1006 is positioned such that friction between the horizontalbrake 1116 and the outer lower surface 1120 of the extension bar 1000 issufficiently limited to allow the extension bar 1000 to extend andretract relative to the wheel bracket 1002. The brake foot 1006 is alsopositioned such that friction between the vertical brake 1118 and thecurved outer surface 1079 is sufficiently small to allow the wheelbracket 1002 and extension bar 1000 to rotate relative to the platform1004 and the upper rod 14 about axis 1042. The second end 1132 of theextension bar 1000 is closer to the upper rod 14 in the releasedposition than in the braked position, but only by a slight amount asdictated by the amount of compression and expansion experienced bybrakes 1116, 1118 when moving between braked and released positions anddepending upon the extent of extension and retraction of bar 1000relative to rod 14. In other words, the first end 1010 of the extensionbar 1000 is positioned further upwardly in the released position than inthe braked position.

As the extension bar 1000 rotates from the released position to thebraked position, the wheels 1064 remain substantially in place relativeto the tracks 1012 of the extension bar 1000, such that the extensionbar 1000 and wheels 1064 can rotate about the second axis 1060 therebymoving the first end 1010 of the extension bar 1000 downwardly and thesecond end 1132 of the extension bar 1000 upwardly and away from theupper rod 14. As the first end 1010 of the extension bar 1000 movesdownwardly, the outer lower surface 1120 of the extension bar 1000pushes against the horizontal brake 1116, causing the brake foot 1006 torotate about the third axis 1062 such that the vertical brake 1118pushes against the curved outer surface 1079 of the platform 1004. Asthe extension bar 1000 rotates from the braked position to the releasedposition, the wheels 1064 remain substantially in place relative to thetracks 1012 of the extension bar 1000, such that the extension bar 1000and wheels 1064 rotate about the second axis 1060 causing the first end1010 of the extension bar 1000 to move upwardly and the second end 1132of the extension bar 1000 to move downwardly and toward the upper rod14. As the first end 1010 of the extension bar 1000 moves upwardly, theouter lower surface 1120 of the extension bar 1000 stops pushing againstthe horizontal brake 1116 (or, at least the force with which surface1120 of bar 1000 contacts brake 1116 is lessened sufficiently to permitmovement of bar 1000 relative to brake 1116) and releases the brake foot1006 to rotate about the third axis 1062 such that the vertical brake1118 stops pushing against the curved outer surface 1079 of the platform1004 (or, at least the force with which brake 1118 contacts surface 1079is lessened sufficiently to permit rotation of bar 1000 about axis1062).

The extension bar 1000 is also rotatable relative to the upper rod 14about the first axis 1042 as shown in FIGS. 40 and 44. The direction ofrotation of the extension bar is indicated by arrow 1142. As theextension bar 1000 rotates, upper and lower thrust washers 1072, 1074,the bolt 1076, the wheel bracket 1002, and the platform 1004 cooperatesuch that the wheel bracket 1002 rotates relative to the platform 1004.When torque is applied to the first end 1010 of the extension bar 1000along the direction of rotation as indicated by arrow 1142, the torqueis transmitted from one of the inner surfaces 1014 of the extension bar1000 to one of the arms 1032 of the wheel bracket 1002 such that thewheel bracket 1002 responds by rotating about axis 1042. It should beappreciated that other mechanisms for rotating the bar 1000 relative tothe upper rod 14 are contemplated within the present disclosure. Forexample, the wheel bracket 1002 may be fixed to the platform 1004, andthe platform 1004 may have a rotatable part therein, such as a bearing.

When a patient's arm is supported by the lateral distractor strap 500,the weight of the patient's arm applies a downward force to the firstend 1010 of the extension bar 1000 in the direction indicated by arrow1026, and the lateral distractor strap 500 applies a correspondinglateral distraction force to the patient's arm. The downward forceapplied by the weight of the patient's arm keeps the extension bar 1000in the braked position. When a physician supports or partially supportsthe weight of the patient's arm to release downward force from the firstend 1010 of the extension bar 1000, the extension bar 1000 moves towardthe released position. When the extension bar 1000 is in the releasedposition, the physician is able to reposition the patient's arm andthereby extend or retract the extension bar 1000 toward the extended orretracted position. When the extension bar 1000 is in the releasedposition, the physician may reposition the patient's arm and therebyrotate the extension bar 1000 relative to the upper rod 14 about thefirst axis 1042. When the physician has finished repositioning thepatient's arm, the physician releases the patient's arm, therebyreapplying downward force to the first end 1010 of the extension bar1000 and moving the extension bar 1000 from the released position intothe braked position. It is to be appreciated that the physician mayreposition the patient's arm by adjusting the shoulder distractionapparatus 400 directly. For example, a sterile handle may be attached tothe extension bar 1000. When the weight of the patient's arm issupported or partially supported such that the extension bar 1000 is inthe released position, the sterile handle may be grasped by a physicianor other sterile personnel to rotate, extend, or retract the extensionbar 1000 relative to the upper rod 14.

In the third embodiment, the shoulder distraction apparatus 400 issubstituted by a shoulder distraction apparatus 2000 that includes anextension bar 2002, a hanger 2004 attached to the extension bar 2002,and an adjustment assembly 2006, as shown in FIGS. 88-94. Referring toFIG. 94, lateral traction force is applied to the patient's arm byattaching the patient's arm to the lateral distractor strap 500, whichhangs from a pin 2008 of the hanger 2004. The extension bar 2002 and thehanger 2004 are guided and positioned by the adjustment assembly 2006,which is configured to respond to movement of the surgical armpositioning system 8 and the patient's arm.

Referring now to FIGS. 88 and 89, the adjustment assembly 2006 includesa mounting bracket 2010, a wheel bracket 2012, a brake foot 2014, and aplatform 2016. The mounting bracket 2010 is mounted to the upper rod 14to mount the adjustment assembly 2006 to the frame 10. The wheel bracket2012 is coupled to the mounting bracket 2010 and can pivot about an axis2020, as will be described in the further detail below. The brake foot2014 is coupled to the wheel bracket 2012 by a pin 2022 that extendsacross a gap 2024 of the wheel bracket 2012 (best seen in FIG. 90) andthrough an aperture (not shown) of the brake foot 2014. The brake foot2014 can pivot about the pin 2022 to contact the platform 2016, whichencircles the mounting bracket 2010. In some embodiments, the brake foot2014 and the platform 2016 are both made of metal. As shown in FIG. 94,a cover 2005 surrounds and protects the adjustment assembly 2006.

Referring to FIGS. 90, 93 and 94, the wheel bracket 2012 is configuredto guide the extension bar 2002 to extend and retract in the directionof arrow 2028. The wheel bracket 2012 has two arms 2054 and a base 2050.Two wheels 2056 are attached to the arms 2054 by axels 2058 such thatthe wheels 2056 face into the gap 2024 of the wheel bracket 2012, asshown in FIG. 90. In the illustrative embodiment, each wheel has anannular flange 2065 which serves as a thrust bearing. The extension bar2002, shown in FIG. 94, has an I-shaped cross section to provide tracks(not shown) that engage the wheels 2056. The brake foot 2014 can pivotabout the pin 2022 to contact a lower surface 2029 of the extension bar2002. Interaction between the wheels 2056 and the tracks guide theextension bar 2002 as it extends and retracts relative to the adjustmentassembly 2006. Friction between the lower surface 2029 of the extensionbar 2002 and the brake foot 2014 causes resistance to extension andretraction of extension bar 2002. In some embodiments, this resistanceis sufficient to maintain the position of the extension bar 2002 but canbe overcome by the operator to extend or retract extension bar 2002.Extension and retraction of the extension bar can be locked when a notchin an end of the extension bar 2002 opposite the mounting bracket isheld by a pin (not shown) located in on the upper rod 14.

Referring now to FIGS. 89 and 93, the mounting bracket 2010 is alsoconfigured to guide the extension bar 2002 to rotate about axis 2020. Afirst hole 2090 extends through the base 2050 of the wheel bracket 2012and a second hole 2092 extends through the mounting bracket 2010 and isaligned with the first hole 2090. A bolt 2062 and a flange bearing 2064surrounding the bolt 2062 (shown in FIG. 91) extend through the firstand second holes 2090 and 2092 with a head 2066 of the bolt 2062 restingagainst the base 2050 of the wheel bracket 2012. Opposite the head 2066of the bolt 2062, a nut 2068 is threaded onto the bolt 2062 and disposedagainst the mounting bracket 2010. The bolt 2062 is aligned with axis2020. As shown in FIG. 89, when the wheel bracket rotates about axis2020, the brake foot 2014 can pivot about the pin 2022 to contact theplatform 2016. Friction between the brake foot 2014 and the platform2016 causes resistance to rotation of the extension bar 2002. In someembodiments, this resistance is sufficient to maintain the position ofthe extension bar 2002 but can be overcome by the operator to rotateextension bar 2002. Referring to FIG. 92, rotation of the extension barcan be further resisted by a pin 2070 that extends from the mountingbracket 2010 and can be received by an opening (not shown) in the wheelbracket 2012. Rotation of the extension bar 2002 can be locked when anend of the extension bar opposite the mounting bracket is held in a gap2080 of a block 2082 that is attached to the upper rod 14, as best seenin FIG. 70.

The hanger 2004 is attached to a first end 2001 of the extension bar2002, and the lateral distractor strap 500 hangs from the pin 2008 ofthe hanger 2004, as shown in FIG. 94. The lateral distractor strap 500is adapted to receive a patient's arm such that a lateral distractionforce is applied to the patient's arm and a corresponding downward forceis applied to the first end 2001 of the extension bar 2000 in thedirection indicated by arrow 2029.

Referring now to FIG. 95, in some embodiments, a tensiometer 1800 hangsfrom the pin 2008 and the lateral distractor strap hangs from thetensiometer 1800. The tensiometer 1800 has a clip 1802 for attaching tothe pin 2008 of the hanger 2004. Opposite the pin, a hook 1804 receivesthe lateral distractor strap 500.

The lateral distractor strap 500 described herein creates a sterileinteraction point, adjustable in length, for the physician to apply orremove traction force to the patient's arm. The lateral distractor strap500 has a connector 502 for attaching to the hanger 436 of the shoulderdistraction apparatus 400, as shown in FIG. 18. In some embodiments, theconnector 502 is a metal loop. The connector 502 is attached to aconnection tether 504 that forms a loop 506 around the connector. Insome embodiments, the connection tether 504 is a webbing strap.

The connection tether 504 is attached to a buckle 508. A cinch strap 510having a first end 512 and second end 514 is routed through the buckle508 such that the length of the cinch strap 510 is adjustable.Illustratively, the cinch strap 510 comprises a webbing strap. In someembodiments, the first end 512 of the cinch strap 510 is pulled throughthe buckle 508 to shorten the length between the connection tether 504and the second end 514 of the cinch strap 510. In some embodiments, thebuckle 508 is a ladderlock type of buckle. In further embodiments, thebuckle 508 is a cam buckle or a strap adjuster. The buckle 508 may beany device capable of adjusting the distance between the buckle 508 andthe second end 514 of the cinch strap 510 and is not limited to theembodiments described herein. The buckle 508 interacts with the cinchstrap 510 such that when the second end 514 of the cinch strap 510 ispulled away from the connection tether 504, the buckle 508 resistslengthening the distance between connection tether 504 and the secondend 514 of the cinch strap 510.

In some embodiments, the second end 514 of the cinch strap 510 isattached to a sleeve connector 516 that is attached to a sleeve member518 as shown in FIG. 18. Illustratively, the sleeve connector 516 is aplastic loop. The sleeve member 518 may be constructed of any materialcapable of supporting the patient's arm during surgery. In someembodiments, the sleeve member 518 comprises aluminum. The sleeve member518 may include a fastener 520 for opening and closing the sleeve member518 to assist in placing the sleeve member 518 around the patient's armor removing the patient's arm from the sleeve member 518.

In some embodiments, as shown in FIG. 19, the second end 514 of thecinch strap 510 is attached to a receiving end 522 of fastener 520. Asleeve strap 524 having a first end 526 and a second end 528 is attachedat the first end 526 of the sleeve strap 524 to the second end 514 ofthe cinch strap 510. Illustratively, the sleeve strap 524 is wider thanthe cinch strap 510. A foam pad 530 for interfacing with the skin of thepatient's upper arm is attached to the sleeve strap 524. The second end528 of the sleeve strap 524 is attached to a prong end 532 of thefastener 520. The prong end 532 is capable of connecting to thereceiving end 522 of the fastener 520.

The patient's arm may be placed on the foam pad 530 of the sleeve member518. The second end 528 of the sleeve strap 524 is moved around thepatient's arm to the first end 526 of the sleeve strap 524, and theprong end 532 is inserted into the receiving end 522 such that thesleeve member 518 forms a closed loop around the patient's arm.

The sleeve member 518 forms a closed loop around the patient's arm, andthe connector 502 is attached to the hanger 436 such that the sleevemember 518 applies traction to the patient's arm and supports the loadof the patient's arm. The physician or other caregiver shortens thedistance between the connection tether 504 and the second end 514 of thecinch strap 510 to apply additional lateral traction to the patient'sarm. The physician or other caregiver lengthens the distance between theconnection tether 504 and the second end 514 of the cinch strap 510 torelease lateral traction from the patient's arm.

Illustratively, the lateral distractor strap 500 is sterilized prior touse. In some embodiments, sterilization is performed using ultraviolet(UV) irradiation. The lateral distractor strap 500 may be sterilized andpackaged as such. In further examples, the lateral distractor strap 500is disposable. The sterility of the lateral distractor strap 500 allowsa sterile physician to adjust lateral traction applied to the patient'sarm during surgery without assistance from non-sterile personnel. It isalso within the scope of this disclosure for the lateral distractionstrap 500 to be sterilized in a chamber using ethylene oxide gas. Thus,the materials from which strap 500 is made are each capable ofwithstanding exposure to ethylene oxide gas.

The connection member 48 includes a sterile connection 600 as shown inFIG. 20. The sterile connection 600 includes a receiving assembly 610adapted to receive a clip 700 as shown in FIGS. 20-21. The receivingassembly 610 is operable to attach to the surgical arm positioningsystem 8. The clip 700 is operable to attach to a sterile wrap 800 asshown in FIGS. 28-34. The sterile connection 600 described hereincontrols the patient's arm rotation by connecting the patient's handand/or forearm to the surgical arm positioning system 8. The sterileconnection 600 is designed to work with the surgical arm positioningsystem 8 to transmit a distal traction force and torque to the patient'sarm.

The clip 700 has a distal end 702 and a proximal end 704 as shown inFIG. 22. The clip 700 includes a snap feature 706 and two wide features708 near the distal end 702 attached to a distal cross portion 709. Thesnap feature 706 is made of a material having limited flexibility. Insome embodiments, the snap feature 706 is made of plastic. Two clip arms710 extend from the distal cross portion 709 to the proximal end 704.The clip arms 710 each have an opening or slot 712 formed therein asshown in FIG. 21.

Illustratively, dimensions for one embodiment of the clip 700 are shownin Table 1 below in reference to the markings A-K shown in FIG. 23. Thedimensions shown in Table 1 relate to one embodiment of the presentdisclosure and are not to limit possible dimensions and measurements ofother embodiments of the clip 700.

TABLE 1 Dimensions of the Clip 700 as shown in FIG. 23. Label Distance(inches) A 4.00 B 0.55 C 0.15 D 0.35 E 1.50 F 6.50 G 1.27 H 0.83 I 1.50J 0.36 K 0.24

The receiving assembly 610 includes a buckle 612 as shown in FIGS. 20and 24. The buckle 612 has wide feature receiving gaps 614 and snapfeature receiving holes 617 as shown in FIG. 24. The buckle 612 isconfigured to receive the clip 700 when snap feature 706 is aligned withsnap feature receiving holes 617 and the wide features 708 are alignedwith the wide feature receiving gaps 614. The snap feature 706 comprisesone or more flexible fingers and is made of plastic in some embodiments.The buckle 612 may be plastic, metal, or other materials. When thefeatures 706, 708 are aligned with snap feature receiving holes 617 andthe wide feature receiving gaps 614 and the clip 700 and buckle 612 arepushed together, the snap feature 706 flexes to fit through snap featurereceiving holes 617 and the wide features 708 fit into the wide featurereceiving gaps 614 to attach buckle 612 and clip 700 together.

The wide features 708 do not necessarily lock to the wide featurereceiving gaps 614. The interaction between the snap feature 706 and thesnap feature receiving holes 617 prevents the clip 700 fromdisconnecting from the receiving assembly 610 due to axial force. Theinteraction between the wide features 708 and the wide feature receivinggaps 614 provides the benefit of transmitting torque between buckle 612and clip 700 while limiting deformation of the clip 700 when the clip700 is made of a flexible material such as plastic. The clip 700 may beremoved from buckle 612 by squeezing, pressing, or pinching the fingersof snap feature 706 together and pulling the clip 700 away from thebuckle 612.

The buckle 612 is connected to a clip adaptor 616 as shown in FIG. 25.The clip adaptor 616 has a proximal end 618 that is operable to receiveand transmit torque to the buckle 612 and a distal end 620 having a rim622.

The clip adaptor 616 engages a connector 624 having a body portion 626attached to a cap 628 as shown in FIGS. 26 and 27. The body portion 626extends into a threaded portion 629 that is externally threaded. Thethreaded portion 629 is attached to a connector hook 630. The bodyportion 626, the cap 628, the threaded portion 629, and connector hook630 are illustratively formed from a monolithic piece of material. Thebody portion 626 resides within the rim 622 of the clip adaptor 616 suchthat the body portion 626 is movable within the clip adaptor 616. Thediameter of the cap 628 is greater than the diameter of the openingdefined by the rim 622 such that contact between the cap 628 and the rim622 prevents the clip adaptor 616 from sliding off of the connector 624.The force of the contact between the cap 628 and the rim 622 createssufficient friction between the cap 628 and the rim 622 to preventrotation and allow torque to be transferred therebetween.

The threaded portion 629 of the connector 624 is threaded within a nut632 shown in FIGS. 20 and 21. The nut 632 has a proximal end 633 incontact with the distal end 620 of the clip adaptor 616. As the nut 632rotates and moves closer to the clip adaptor 616, the proximal end 633of the nut 632 applies pressure to the distal end 620 of the clipadaptor 616, thereby applying pressure between the rim 622 of the clipadaptor 616 and the cap 528 of the connector 624. The pressure appliedto the clip adaptor 616 by the connector 624 may be sufficient toprevent rotation of the clip adaptor 616 relative to the connector 624and thereby preventing rotation of the buckle 612 and, if attached, theclip 700 relative to the connector 624.

Illustratively, the clip adaptor 616, the buckle 612, and the clip 700may be adjusted by rotation relative to the connector 624. First, thenut 632 is rotated in a first direction such that the proximal end 633of the nut 632 is moved away from the distal end 620 of the clip adaptor616. Second, the clip adaptor 616 and attached components are rotated.Third, the nut 632 is rotated in a second direction opposite to thefirst direction such that the proximal end 633 of the nut 632 is movedtoward the distal end 620 of the clip adaptor 616. One skilled in theart will appreciate that adjustment of the clip adaptor 616, the buckle612, and the clip 700 relative to the connector 724 that includesrotation of the nut 632 is within the scope of this disclosure.

The threaded portion 629 of the connector 624 is also threaded within aknob 634 as shown in FIGS. 20, 21 and 27. The knob 634 is in contactwith a cable adaptor 636 and surrounded by a flange 638 such that partof the flange 638 is located between the knob 634 and the cable adaptor636. The cable adaptor 636 is sometimes referred to herein as aconnection member. Thus, cable adaptor 636 is an example of theconnection member 48 shown diagrammatically in FIGS. 1, 11 and 12. Thus,the cable adaptor 636 connects to two cable ends 640 of cable 46. Thecable adaptor 636 receives the connector hook 630 such that theconnector hook 630 hooks around a pin 642 of the cable adaptor 636 andprevents the connector 624 from being pulled off of the cable adaptor636. Rotation of the knob 634 distally pushes the knob 634 against thecable adaptor 636, thereby pulling the connector hook 630 into the pin642 of the cable adaptor 636 and locking the connector hook 630 to thecable adaptor 636.

Referring now to FIG. 78A, in some embodiments, the flange 638 is adisposable shield 2900. The shield may be made of translucent whitepolyethylene or any other suitable plastic or material. The shield 2900is formed from a circular disc 2902 having a diameter of 7 inches andhaving a square hole 2904 therein. The square may have sides having alength A of 1.15 inches. Referring to FIG. 78B, the corners 2910 of thesquare hole 2904 lead to a narrow passageway 2908 having a length B of0.20 inches and width C of 0.01 inches. The narrow passageway 2908 leadsto a circular opening 2906 having a diameter of 0.13 inches.

In some embodiments, the receiving assembly 610 may be further securedto the cable adaptor 636 to prevent inadvertent decoupling by sliding apiece that interacts with a catch. Parts for further securing thereceiving assembly 610 to the cable adaptor 636 are located on thesterile end of the flange 638 to maintain sterility.

Illustratively, the cable ends 640 are cables of a non-sterile supportdevice such as the surgical arm positioning system 8. The cable ends 640and cable adaptor 636 form a non-sterile attachment point for thereceiving assembly 610 to attach to the non-sterile surgical armpositioning system 8. The interaction between connector hook 630 and thepin 642 of the cable adaptor 636 may be substituted by other assembliescapable of connecting the receiving assembly 610 to the cable ends 640,such as other assemblies having a hook, a loop, or a key. One skilled inthe art will appreciate the mechanical attachment may be any structurecapable of attaching the receiving assembly 610 to a surgical armpositioning system 8 and is not limited to the structures shown anddescribed herein.

In a second embodiment, the connection member 48 alternatively includesa sterile connection 1600. The sterile connection 1600 includes areceiving assembly 1610 adapted to receive a clip 1700 as shown in FIGS.55 and 56. The receiving assembly 1610 is attachable to the surgical armpositioning system 8, and the clip 1700 is attachable to a sterile wrap800 shown in FIGS. 28-34. The sterile connection 1600 described hereincontrols the patient's arm rotation by connecting the patient's handand/or forearm to the surgical arm positioning system 8. The sterileconnection 1600 is designed to work with the surgical arm positioningsystem 8 to transmit a distal traction force and torque to the patient'sarm.

The clip 1700 has a distal end 1702 and a proximal end 1704 as shown inFIG. 57. The clip 1700 includes a snap feature 1706, a loop feature1707, and two wide features 1708 near the distal end 1702 attached to adistal cross portion 1709. The snap feature 1706 is made of a materialhaving limited flexibility. In some embodiments, the snap feature 1706is made of plastic. Two clip arms 1710 extend from the distal crossportion 1709 to the proximal end 1704.

The receiving assembly 1610 includes a buckle 1612 as shown in FIGS. 55and 58. The buckle 1612 has wide feature receiving cavities 1614 and asnap feature receiving hole 1617 as shown in FIG. 58. The buckle 1612 isconfigured to receive the clip 1700 when snap feature 1706 and loopfeature 1707 are aligned with the snap feature receiving hole 1617 andthe wide features 708 are aligned with the wide feature receivingcavities 1614. The snap feature 1706 comprises one or more flexiblefingers and is made of plastic in some embodiments. The buckle 1612 maybe plastic, metal, or other materials. When the features 1706, 1707,1708 are aligned with the snap feature receiving hole 1617 and the widefeature receiving cavities 1614 and the clip 1700 and buckle 1612 arepushed together, the snap feature 1706 flexes to fit through snapfeature receiving hole 1617 and the wide features 1708 fit into the widefeature receiving cavities 1614 to attach buckle 1612 and clip 1700together.

The wide features 1708 do not necessarily lock to the wide featurereceiving cavities 1614. The interaction between the snap feature 1706and the snap feature receiving hole 1617 prevents the clip 1700 fromdisconnecting from the receiving assembly 1610 due to axial force. Theinteraction between the wide features 1708 and the wide featurereceiving cavities 1614 provides the benefit of transmitting torquebetween buckle 1612 and clip 1700 while limiting deformation of the clip1700 when the clip 1700 is made of a flexible material such as plastic.The clip 1700 may be removed from buckle 1612 by squeezing, pressing, orpinching the fingers of snap feature 1706 together and pulling the clip1700 away from the buckle 1612.

The buckle 1612 is connected to a clip adaptor 1616. The clip adaptor1616 has a proximal end 1618 that is operable to receive and transmittorque to the buckle 1612 and a distal end 1620 having a rim 1622 asshown in FIG. 59. Compared to buckle 612, buckle 1612 is about twice aslong when measured from its proximal end 1618 to its distal end 1620. Insome embodiments, the clip adaptor 1616 has a hole therein positionedsuch that when the clip 1700 is connected to the receiving assembly1610, the hole in the clip adaptor 1616 is aligned with the loop feature1707. A clip pin 1644 may be inserted through the hole in the clipadaptor 1616 and through the loop feature 1707 to further prevent theclip 1700 from detaching from the receiving assembly 1610, as shown inFIGS. 55 and 56.

The receiving assembly 1610 also comprises a connector 1624 including adistal body portion 1629, a middle body portion 1626, a proximal bodyportion 1631, a distal knob receiving threaded portion 1650, a proximalknob receiving threaded portion 1652, a cap 1628, and a connector hook1630 as shown in FIG. 60. The connector 1624 is illustratively formedfrom a monolithic piece of material. The hook 1630 and the cap 1628 arelocated on opposite ends of the connector 1624.

A distal knob receiving nut threadedly engages the distal knob receivingthreaded portion 1650, and a proximal knob receiving nut threadedlyengages the proximal knob receiving threaded portion 1652. The cap 1628of the connector 1624 resides within the clip adaptor 1616 such that thehook 1630 extends outside of the clip adaptor 1616 and away from thedistal end 1620 of the clip adaptor 1616 and such that the cap 1628 canslide within the clip adaptor 1616. The diameter of the opening definedby the rim 1622 of the clip adaptor 1616 is smaller than the diameter ofthe cap 1628 such that contact between the cap 1628 and the rim 1622prevents the clip adaptor 1616 from sliding off of the connector 1624.

The proximal knob receiving threaded portion 1652 has a proximal knob1632 threaded thereto as shown in FIGS. 55 and 56. The proximal knob1632 has a proximal end 1633 in contact with the distal end 1620 of theclip adaptor 1616. As the proximal knob 1632 rotates and moves closer tothe clip adaptor 1616, the proximal end 1633 of the proximal knob 1632applies pressure to the distal end 1620 of the clip adaptor 1616,thereby applying pressure between the rim 1622 of the clip adaptor 1616and the cap 1628 of the connector 1624. When the proximal knob 1632 istightened, the pressure applied to the clip adaptor 1616 by theconnector 1624 is sufficient to prevent rotation of the clip adaptor1616 relative to the connector 1624 and thereby preventing rotation ofthe buckle 1612 and, if attached, the clip 1700 relative to theconnector 1624.

Illustratively, the clip adaptor 1616, the buckle 1612, and the clip1700 may be rotated relative to the connector 1624 when the proximalknob 1632 is loosened. First, the proximal knob 1632 is rotated in afirst direction such that the proximal end 1633 of the proximal knob1632 is moved away from the distal end 1620 of the clip adaptor 1616.Second, the clip adaptor 1616, the buckle 1612, and the clip 1700 arerotated. Third, the proximal knob 1632 is rotated in a second directionopposite the first direction such that the proximal end 1633 of theproximal knob 1632 is moved toward the distal end 1620 of the clipadaptor 1616.

The distal knob receiving threaded portion 1650 of the connector 1624 isfixed to a distal knob 1634 shown in FIGS. 55 and 56. The distal knob1634 pushes a flange 638 against a cable adaptor 636 as shown in FIGS.55 and 56. The cable adaptor 636 is sometimes referred to herein as aconnection member. Thus, cable adaptor 636 is an example of theconnection member 48 shown diagrammatically in FIGS. 1, 11 and 12. Thus,the cable adaptor 636 connects to two cable ends 640 of cable 46. Thecable adaptor 636 receives connector hook 1630 such that the connectorhook 1630 hooks around a pin 642 of the cable adaptor 636 and preventsthe connector 1624 from being pulled off of the cable adaptor 636.Rotation of the distal knob 1634 distally pushes the distal knob 1634against the cable adaptor 636, thereby pulling the connector hook 1630against the pin 642 of the cable adaptor 636 and securing the connectorhook 1630 to the cable adaptor 636.

When compared to nut 632, the proximal knob 1632 is wider to furtherprevent inadvertently decoupling of the clip 1700 from the buckle 1612.When compared to buckle 612, buckle 1612 has snap feature shields 1613extending distally therefrom to further prevent inadvertently decouplingthe clip 1700 from the buckle 1612.

In some embodiments, the receiving assembly 1610 may be further securedto the cable adaptor 636 to prevent inadvertent decoupling by sliding apiece that interacts with a catch. Parts for further securing thereceiving assembly 1610 to the cable adaptor 636 are located on thesterile end of the flange 638 to maintain sterility.

When the sterile connection is attached to the patient's arm, the cableends 640 are pulled in opposing directions. Tension in the cable ends640 prevents, to a degree proportional to the amount of tension, thereceiving assembly 610, or alternatively receiving assembly 1610, and byextension the clip 700, or alternatively the clip 1700, and thepatient's arm, from rotating when the patient's arm is attached. Thetension of the cable ends 640 resists torque created by any attempt torotate of the patient's arm and allows the sterile connection 600, oralternatively sterile connection 1600, to maintain a rotated position ofthe patient's arm.

Illustratively, the cable adaptor 636 and cable ends 640 arenon-sterile, while the clip 700, the buckle 612, the clip adaptor 616,the nut 632, the knob 634, and the connector 624, or alternatively theclip 1700, the buckle 1612, the clip adaptor 1616, the proximal knob1632, the distal knob 1634, and the connector 1624, are sterile. Theflange 638, itself sterile, separates the sterile components from thenon-sterile components. During adjustment of nut 632 and knob 634, oralternatively of the proximal knob 1632 and the distal knob 1634, theflange 638 prevents sterile personnel from coming into contact withnon-sterile components. One skilled in the art will appreciate that theflange 638 may be replaced by other barriers capable of separating thecable adaptor 636 from sterile components that prevent the sterileoperator from inadvertently touching non-sterile components. In someembodiments, the sterile connection 600, or alternatively the sterileconnection 1600, is designed such that the sterile operator may grabcomponents between the clip 700, or alternatively the clip 1700, and theflange 638 without coming into contact with non-sterile components.

The receiving assembly 610 may be disassembled, allowing the clip 700,the buckle 612, the clip adaptor 616, the nut 632, the knob 634, and theconnector 624 to be sterilized between uses. By rotating the knob 634 tothereby move it proximally, the connector hook 630 may be detached fromthe pin 642 of the cable adaptor 636. Next, the knob 634 may be rotatedto be removed from the assembly. In some embodiments, the nut 632, theconnector 624, the clip adaptor 616, and the buckle 612 are removed fromthe rest of the sterile connection 600, as well.

Similarly, the receiving assembly 1610 may be disassembled, allowing theclip 1700, the buckle 1612, the clip adaptor 1616, the proximal knob1632, the distal knob 1634, and the connector 1624 to be sterilizedbetween uses. By rotating the distal knob 1634 to thereby move itproximally, the connector hook 1630 may be detached from the pin 642 ofthe cable adaptor 636. Next, the distal knob 1634 may be rotated to beremoved from the assembly. In some embodiments, the proximal knob 1632,the connector 1624, the clip adaptor 1616, and the buckle 1612 areremoved from the rest of the sterile connection 1600, as well.

Disassembling the receiving assembly 610, or alternatively the receivingassembly 1610, allows smaller individual components to be sterilizedrather than larger components. Disassembling the receiving assembly 610,or alternatively the receiving assembly 1610, into smaller componentsprovides the advantage of allowing for smaller sterilization devices. Insome embodiments, the components may be sterilized using an autoclave.In further embodiments, the clip 700 may be made of a sterilizeddisposable material. In still further embodiments, the clip 700 may bereusable and sterilized between uses.

In the third embodiment, the connection member 48 alternatively includesa sterile connection 2600. The sterile connection 2600 includes areceiving assembly 2610 adapted to receive a clip 2700 as shown in FIGS.75 and 86. The receiving assembly 2610 is attachable to the surgical armpositioning system 8, and the clip 2700 is attachable to a sterile wrap800 shown in FIGS. 76-87. The sterile connection 2600 described hereincontrols the patient's arm rotation by connecting the patient's handand/or forearm to the surgical arm positioning system 8. The sterileconnection 2600 is designed to work with the surgical arm positioningsystem 8 to transmit a distal traction force and torque to the patient'sarm.

Referring now to FIG. 72, the clip 2700 has a distal end 2702 and aproximal end 2704. The clip 2700 includes a snap feature 2706, a loopfeature 2707, and two wide features 2708 near the distal end 2702attached to a distal cross portion 2709. Two prongs 2715 extend from theloop feature 2707 on opposite sides of the loop feature 2707. The snapfeatures 2706 are made of a material having limited flexibility suchthat the operator can squeeze the snap features 2706 toward each other.After the operator releases the snap features 2706, the snap features2706 spring back away from each other to their equilibrium positions. Insome embodiments, the snap features 2706 are made of plastic. Two cliparms 2710 extend from the distal cross portion 2709 to the proximal end2704.

In the third embodiment, the dimensions of the clip 2700 are the same asthose of clip 700 except for those shown in Table 2 below in referenceto the markings A-J shown in FIG. 81A-81C. The dimensions shown in Table2 and relate to the third embodiment of the present disclosure and arenot to limit possible dimensions and measurements of other embodimentsof the clip 2700.

TABLE 2 Dimensions of the Clip 2700 as shown in FIG. 81A-81C. LabelDistance (inches) A 0.260 B 0.360 C 6.52  D 0.560 E 4.340 F 1.440 ±0.003 G 0.560 H 0.100 I 0.760 J 0.140

Referring now to FIG. 75, in the third embodiment, the sterileconnection 2600 is the same as the sterile connection 1600 of the secondembodiment, unless described otherwise herein. Additionally, componentsof the sterile connection 2600 and sterile connection 1600 that havereference numbers ending in the same last two digits after “16” and “26”are understood to be identical unless described otherwise herein. Forexample, hypothetical parts 1699 and 2699 would be identical unlessdescribed otherwise herein.

As shown in FIGS. 73 and 75, the receiving assembly 2610 of the sterileconnection 2600 includes a buckle 2612 that has a modified shapecompared to the buckle 1612. The buckle 2612 has two first pin holes2660 for receiving a clip pin 1644. Additionally, the buckle 2612 hastwo second pin holes 2662. When the clip 2700 is inserted into thebuckle 2612, the pin holes 2662 are positioned between the two prongs2715 of the clip 2700, as shown in FIG. 73. Pins 2663 may be insertedinto the pin holes 2662 to further prevent the clip 2700 fromdisengaging from the buckle 2612 and detaching from the receivingassembly 2610 when the surgical arm positioning system 8 is in use witha patient.

Referring now to FIG. 74, the receiving assembly 2610 of the sterileconnection 2600 also includes a connector 2624 that is modified comparedto the connector 1624. The connector 2624 includes a middle body portion2626, a proximal knob receiving portion 2652, a cap 2628, and aconnector hook 2630 as shown in FIG. 74. The connector 2624 issurrounded by wide washers 2655, narrow washers 2651, and a flangewasher 2650. The hook 2630 and the cap 2628 are located on opposite endsof the connector 2624.

Referring now to FIGS. 74 and 75, a distal knob 2634 receiving nutengages the flange washer 2650, and a proximal knob receiving nutengages one of the wide washers 2655. The cap 2628 of the connector 2624resides within the clip adaptor 1616 (shown in FIG. 59) in contact withthe rim 1622 of the clip adapter 1616 such that the hook 2630 extendsoutside of the clip adaptor 1616 and away from the distal end 1620 ofthe clip adaptor 1616. The diameter of the opening defined by the rim1622 of the clip adaptor 1616 is smaller than the diameter of the cap2628 such that contact between the cap 2628 and the rim 1622 preventsthe clip adaptor 1616 from sliding off of the connector 2624.

Referring now to FIGS. 74 and 75, the proximal knob 2632 has a proximalfacing inner surface (not shown) in contact with the wide washer 2655such that the proximal end 2633 of the proximal knob faces toward theclip 2700. The distal knob 2634 has a distal facing inner surface (notshown) in contact with the flange washer 2650. A spring 2654 is disposedabout the connector 2624 distal to the wide washers 2655. When the hook2630 of the connector 2624 is received by the cable adaptor 636, thespring compresses as the distal knob 2634 moves closer to the cableadaptor 636. As a result of the spring 2654 compressing, the proximalknob 2632 is pushed toward the clip adaptor 1616 such that the proximalend 2633 of the proximal knob 2632 applies pressure to the distal end1620 of the clip adaptor 1616, thereby applying pressure between the rim1622 of the clip adaptor 1616 and the cap 2628 of the connector 2624.Additionally, when the spring 2654 is compressed and the hook 2630engages the pin 642 (shown in FIG. 27) of the connector 636, a proximalsurface of the distal knob 2634 applies pressure to a distal surface ofthe flange washer 2650, thereby pulling the hook 2630 toward the pin 642and securing the hook 2630 to the connector 636. When the hook 2630 isattached to the cable adaptor 636, the pressure applied to the clipadaptor 1616 by the connector 2624 is sufficient to prevent rotation ofthe clip adaptor 1616 relative to the connector 2624 and therebypreventing undesired rotation of the buckle 2612 and, if attached, theclip 2700 relative to the connector 2624 during surgery. As such, theoperator can connect sterile connection 2600 to the surgical armpositioning system 8 by first placing the narrow washers 2651, widewashers 2655, spring 2654, clip adaptor 2612 and connector 1616,proximal knob 1632, and distal knob 1634 around the connector 2624;second, pushing the connector hook 2630 into the cable adaptor 636 tocompress the spring 2654 while engaging the pin 642 of the cable adaptor636 with the connector hook; and third, releasing the sterile connection2600.

A sterile wrap 800, as shown in FIG. 28-31 is used for wrapping aroundthe patient's arm, hand, and wrist and connecting the patient's arm tothe clip 700 which, in turn, connects the patient's arm to the sterileconnection 600. Illustratively, the sterile wrap 800 includes a sheet802 having an interior side 804 having an interior surface and anexterior side 806 having exterior surface. The interior surface is madeof foam, such as a low density sheet of foam, and the exterior surfaceis made of loop material having loops. The loop material is any materialcapable of interacting with a hook material having hooks such that thehooks become attached to the loops, thereby fastening the materialstogether. In other embodiments, fastening may be accomplished by clasps,hooks, snaps, or the like.

The disposable wrap is shaped to wrap onto itself around specific partsof the patient's hand and forearm to support the patient's arm.Supporting the patient's arm by wrapping aids in torque transmission byreducing the amount that the foam can stretch. The sterile wrap 800 isattached to the clip 700 in a way that the patient's skin will not be indirect contact with rigid materials when wrapped by the sterile wrap800.

The sheet includes a wrist portion 808, a first clip cover portion 810,a second clip cover portion 812, and a forearm portion 814. The wristportion 808 is situated at a first edge 816 of the sheet 802. Theforearm portion 814 is situated at a second edge 818 of the sheet 802.

The first clip cover portion 810 extends from the wrist portion 808. Thesecond clip cover portion 812 extends from the forearm portion 814. Thefirst clip cover portion 810 is coupled to the second clip cover portion812 by a hinge portion 820 situated between the first clip cover portion810 and the second clip cover portion 812. The hinge portion 820includes a perforation 822 and two indentations or notches 824 arrangedin a linear pattern.

The wrist portion 808 includes a first strap 826 and a second strap 828.The first strap 826 is attached to a tab 830 having the hook material.The hook material has hooks facing the interior side 804 of the sheet.The exterior side 806 of the second strap 828, having the loop material,is sized to receive the tab 830 of the first strap 826 such that the twostraps 826, 828 adhere due to interaction between the hooks of the tab830 of the first strap 826 and the loops of the exterior side 806 of thesecond strap 828.

The first clip cover portion 810 includes two flaps 832 attached to twotabs 834, each tab having the hook material. The hook material has hooksfacing the interior side 804 of the sheet 802. The exterior side 806 ofthe second clip cover portion 812, having the loop material, receivesthe flaps 832 of the first clip cover portion 810 when the sheet 802 isfolded such that the interior surfaces 804 of the first and second clipcover portions 810, 812 face each other.

The forearm portion 814 includes three straps 836 a, 836 b, 836 c eachattached to one of three tabs 838 a, 838 b, 838 c each having the hookmaterial. The hook material has hooks facing the interior side 804 ofthe sheet 802. A first and a second of the straps 836 a, 836 c of theforearm portion 814 extend in a direction opposite a third of the straps836 b of the forearm portion. The exterior side 806 of forearm portion814, having the loop material, is operable to receive the tabs 838 a,838 b, 838 c of the forearm portion.

Illustratively, dimensions for a sterile wrap 800 are shown in Table 4in reference to the markings A-V as shown in FIG. 29. The dimensionsshown in Table 3 relate to one embodiment of the present disclosure andare not to limit possible dimensions and measurements of the sterilewrap 800.

TABLE 3 Dimensions of the Sterile Wrap 800 as shown in FIG. 29. LabelDistance (inches) A 2 B 3⅞ C 5¼ D 7¼ E 10  F 12¾ G 14¾ H 16½ I 3¼ J 5¾ K9 L 15¼ M 16¾ N 19¾ O 21½ P 24  Q 1½ R 3½ S 2 T ½ U 1½ V 2

The sterile wrap 800 may be attached to the clip 700 by placing the snapfeature 706 of the clip 700 through the perforation 822 and the widefeatures 708 of the clip 700 through the indentations 824.Alternatively, the sterile wrap 800 may be attached to the clip 1700 byplacing the snap feature 1706 and the loop feature 1707 of the clip 1700through the perforation 822 and the wide features 1708 of the clip 1700through the indentations 824. After the clip 700 is placed in the sheet802, each of the flaps 832 of the first clip cover portion 810 areplaced through one of the openings 712 in the clip arms 710 of the clip700, thus forming a loop. Alternatively, after the clip 1700 is placedin the sheet 802, each of the flaps 832 of the first clip cover portion810 are wrapped around one of the clip arms 1710 of the clip 1700, thusforming a loop. The loop is closed by attaching the flaps 832 tothemselves such that two parts of the exterior side 806 of each flap 832are in contact. In some embodiments, the flaps 832 are sewn tothemselves around the openings 712.

When the sterile wrap 800 is not attached to the clip 700, the sheet 802is substantially flat. Thus, the sterile wrap 800 is easily stored orstacked in the flat position along with other wraps 800, if desired.

The disposable wrap is foldable between a flat position, shown in FIGS.28-29, a folded position, shown in FIGS. 30-31, a wrist wrappedposition, shown in FIG. 32, a wrist wrapped folded position, shown inFIG. 33 and a wrist forearm wrapped position, shown in FIG. 34.

To move the sterile wrap 800 from the flat position to the foldedposition, the hinge portion 820 is bent such that the wrist portion 808extends over and is substantially parallel to the second clip coverportion 812 and/or the forearm portion 814. In some embodiments, thesterile wrap 800 may be attached to the clip 700, or alternatively theclip 1700, and packaged in the folded position. Packaging the sterilewrap 800 and the clip 700, or alternatively the clip 1700, together inthe folded position provides the benefit of a conveniently sizedpackage. To further attach the sterile wrap 800 to the clip 700, oralternatively the clip 1700, the sterile wrap 800 may be moved into thefolded position and sewn or stitched to itself parallel to and near thedistal cross portion 709 of the clip 700, or alternatively the distalcross portion 1709 of the clip 1700, as shown in FIG. 30.

After attaching the sterile wrap 800 to the clip 700, or alternativelythe clip 1700, the wrist portion 808 is wrapped around the patient'swrist. The back of the patient's hand is placed against the interiorside 804 of the wrist portion 808 and/or first clip cover portion 810 ofthe sterile wrap 800 with the straps 826, 828 of the wrist portion 808near the patient's wrist and the patient's fingers near the hingeportion 820. The second strap 828 is placed around the patient's wristsuch that the interior side 804 of the sheet 802 is in contact with thepatient's wrist. The first strap 826 is then placed around the secondstrap 828 and the tab 830 is attached to the exterior side 806 of thesecond strap 828. The resulting position of the sterile wrap 800 is awrist wrapped position as shown in FIG. 32.

When the sterile wrap 800 is in the wrist wrapped position, the sheet802 is folded at the hinge portion 820 such that the interior side 804of the forearm portion 814 is in contact with the patient's forearm. Theresulting position of the sterile wrap 800 is a wrist wrapped foldedposition as shown in FIG. 33.

When the sterile wrap is in the wrist wrapped folded position, the thirdstrap 836 b of the forearm portion is moved across the patient's forearmand secured to the exterior side 806 of the forearm portion 814 betweenthe first strap 836 a and the second strap 836 c of the forearm portion814. The first strap 836 a and the second strap 836 c of the forearmportion 814 are moved across the patient's forearm and secured to theexterior side 806 of the forearm portion 814. The flaps 832 of the firstclip cover portion 810 are moved around the clip 700, or alternativelythe clip 1700, and attached to the exterior side 806 of the second clipcover portion 812. The resulting position of the sterile wrap 800 is awrist forearm wrapped position as shown in FIG. 34.

When the sterile wrap 800 is in the wrist forearm wrapped position, thepatient's arm is ready to be connected to the surgical arm positioningsystem 8. Particularly, the clip 700 is attached to the buckle 612 ofthe receiving assembly 610 that, in turn, is attached to the surgicalarm positioning system 8. Alternatively, the clip 1700 is attached tothe buckle 1612 of the receiving assembly 1610 that, in turn, isattached to the surgical arm positioning system 8.

Referring now to FIGS. 76A-87, the sterile wrap 2800, is substituted bysterile wrap 2800 in the third embodiment. As best seen in FIG. 77, thesterile wrap 2800 includes a sheet 2802 having an interior side 2804having an interior surface and an exterior side 2806 having exteriorsurface. The interior surface is made of foam, such as a low densitysheet of foam, and the exterior surface is made of loop material havingloops. The loop material is any material capable of interacting with ahook material having hooks such that the hooks become attached to theloops, thereby fastening the materials together. In other embodiments,fastening may be accomplished by clasps, hooks, snaps, or the like.

The disposable wrap is shaped to wrap onto itself around specific partsof the patient's hand and forearm to support the patient's arm.Supporting the patient's arm by wrapping aids in torque transmission byreducing the amount that the foam can stretch. As shown in FIGS. 77 and79, the sterile wrap 2800 is attached to the clip 2700 in a way that thepatient's skin will not be in direct contact with rigid materials whenwrapped by the sterile wrap 2800.

Referring now to FIGS. 76A and 79, the sheet includes a wrist portion2808, a first clip cover portion 2810, a second clip cover portion 2812,and a forearm portion 2814. The wrist portion 2808 is situated at afirst edge 2816 of the sheet 2802. The forearm portion 2814 is situatedat a second edge 2818 of the sheet 2802.

The first clip cover portion 2810 extends from the wrist portion 2808.The second clip cover portion 2812 extends from the forearm portion2814. The first clip cover portion 2810 is coupled to the second clipcover portion 2812 by a hinge portion 2820 situated between the firstclip cover portion 2810 and the second clip cover portion 2812. Thehinge portion 2820 includes a perforation 2822 and two indentations ornotches 2824 arranged in a linear pattern.

The wrist portion 2808 includes a first strap 2826 and a second strap2828. The first strap 2826 is attached to a tab 2830 having the hookmaterial. The hook material has hooks facing the interior side 2804 ofthe sheet. The exterior side 2806 of the second strap 2828, having theloop material, is sized to receive the tab 2830 of the first strap 2826such that the two straps 2826 and 2828 adhere due to interaction betweenthe hooks of the tab 2830 of the first strap 2826 and the loops of theexterior side 2806 of the second strap 2828.

The first clip cover portion 2810 includes two flaps 2832 attached totwo tabs 2834, each tab having the hook material. The hook material hashooks facing the interior side 2804 of the sheet 2802. The exterior side2806 of the second clip cover portion 2812, having the loop material,receives the flaps 2832 of the first clip cover portion 2810 when thesheet 2802 is folded such that the interior surfaces 2804 of the firstand second clip cover portions 2810 and 2812 face each other.

The forearm portion 2814 includes three straps 2836 a, 2836 b, 2836 ceach attached to one of three tabs 2838 a, 2838 b, and 2838 c eachhaving the hook material. The hook material has hooks facing theinterior side 2804 of the sheet 2802. A first and a second of the straps2836 a, 2836 c of the forearm portion 2814 extend in a directionopposite a third of the straps 2836 b of the forearm portion. Theexterior side 2806 of forearm portion 2814, having the loop material, isoperable to receive the tabs 2838 a, 2838 b, and 2838 c of the forearmportion.

Illustratively, dimensions for a sterile wrap 2800 are shown in Table 4in reference to the markings A-V as shown in FIGS. 76A and 76B. Angle Whas a value of 100°. The dimensions shown in Table 4 relate to oneembodiment of the present disclosure and are not to limit possibledimensions and measurements of the sterile wrap 2800.

TABLE 4 Dimensions of the Sterile Wrap 2800 as shown in FIG. 76A-76C.Label Distance (inches) A 19½ B 18½ C 16½ D 15 E 12¾ F 10 G 7¼ H  1 I  3J 5½ K 8½ L 15¾ M 17¾ N 21¾ O 22½ P 25 Q 1½ R ½ S 0.16 ± 0.05 T    4.25U 1.60 ± 0.05 V 1.00 ± 0.05

Referring now to FIG. 77, the sterile wrap 2800 may be attached to theclip 2700 by placing the snap feature 2706 and loop feature 2707 of theclip 2700 through the perforation 2822 and the wide features 2708 of theclip 2700 through the indentations 2824. As shown in FIGS. 79 and 80,after the clip 2700 is placed in the sheet 2802, each of the flaps 2832of the first clip cover portion 2810 are wrapped around one of the cliparms 2710 of the clip 2700, thus forming a loop. The loop is closed byattaching the flaps 2832 to themselves such that two parts of theexterior side 2806 of each flap 2832 are in contact. In someembodiments, the flaps 2832 are sewn to themselves around the openings2712.

When the sterile wrap 2800 is not attached to the clip 700, the sheet2802 is substantially flat. Thus, the sterile wrap 2800 is easily storedor stacked in the flat position along with other wraps 2800, if desired.

The disposable wrap 2800 is folded around the patients arm to attach thepatient to the clip 2700 and the rest of the surgical arm positioningsystem 8 over several steps, as shown in FIGS. 82-86. Referring to FIG.82, in a first step, with the patient's arm resting against the interiorsurfaces 2804 of the disposable wrap 2800, the second strap is wrappedaround the patient's arm toward the first strap 2826. Next, in a secondstep, the first strap 2826 is wrapped around the patient's arm over thefirst strap 2826. As shown in FIG. 83, in a third step, one of the flaps2832 is folded over the patient's hand, followed by a fourth step offolding the other one of the flaps 2832 over the patient's hand.Referring now to FIG. 84, after the fourth step, the forearm portion2814 is folded over the flaps 2832. As shown in FIG. 85, in a fifthstep, strap 2838 b is folded over the patient's forearm. In a sixthstep, strap 2838 c is folded over the patient's forearm. Strap 2838 a isfolded over the patient's forearm in a seventh step to finish securingthe patient's arm to the clip 2700 by the sterile wrap 2800. Referringnow to FIG. 86, after the patient's arm is secured to the clip 2700, theclip 2700 is inserted into the receiving assembly 2610.

Referring now to FIGS. 87A-87I, the sterile wrap 2800 may be foldedalong with the shield 2900 (shown in FIGS. 78A and 78B) and packaged ina plastic bag 2950. Starting with sterile wrap 2800 in a flat, unfoldedposition, as shown in FIG. 87A, the shield 2900 may be placed onto thewrap 2800 with strap 2836 a placed through the hole 2904 of the shield2900, as shown in FIG. 87B. Next, strap 2836 c is folded over the shield2900, as shown in FIG. 87C, followed by moving first and second straps2826 and 2828 toward the shield 2900, as shown in FIG. 87D. As shown inFIGS. 87E-87G, the flaps 2832 are next folded around the rest of thesterile wrap 2800. Finally, moving from FIG. 87G to FIG. 87H, first andsecond straps 2826 and 2828 around folded around each other such thatthe sterile wrap 2800 is substantially square. As shown in FIG. 87I, thefolded sterile wrap 2800 is inserted into the plastic bag 2950.

In some embodiments, the clip adaptor 616 is substituted by a handle 900as shown in FIGS. 35-37. The handle forms a T-shape (shown in FIG. 35)in some embodiments and forms a J-shape (shown in FIGS. 36 and 37) inother embodiments and has a proximal end 902 that is operable to begripped by the patient's hand and a distal end 904 having a rim 906. Thehandle 900 may be any shape that allows it to be gripped by the patient.The proximal end 902 of the handle may be at an angle of about 78° fromthe distal end 904 in the J-shaped embodiment, for example. However, theangle between the proximal end 902 and the distal end 904 may be anyangle that substantially matches the grip angle of the patient's hand.

A sterile handle cover 908 is fitted to the proximal end 902 of thehandle 900 such that the patient may grip the sterile handle cover 908without making contact with the handle 900. The sterile handle cover 908is stiff but flexible and, in some embodiments, is made of plastic. Thepatient's hand is wrapped around the sterile handle cover 908 and amaterial such as foam is wrapped around the patient's hand to hold thepatient's hand closed around the sterile handle cover 908. The sterilehandle cover 908 may be wrapped or coated in a cushioning material suchas foam. The sterile handle cover 908 slides onto the proximal end 902of the handle and snaps into place with a radial snap feature 910. Theproximal end 902 of the handle 900 has a series of grooves 912 thereinto accept the radial snap feature 910. When the sterile handle cover 908is over the handle 900 and the radial snap feature 910 is in one of thegrooves 912, a release mechanism 914 may be operated to disengage theradial snap feature 910, allowing the handle 900 and the sterile handlecover 908 to be decoupled. In some examples, the release mechanism 914includes a button, a lever, or a knob.

The handle 900 engages the connector 624. The body 626 of the connector624 resides within the rim 906 of the handle 900 such that the body 626is movable within the handle 900. The diameter of the cap 628 is greaterthan the diameter of the opening defined by the rim 906 such thatcontact between the cap 628 and the rim 906 prevents the handle 900 fromsliding off of the connector 624. The force of the contact between thecap 628 and the rim 906 may create sufficient friction between the cap628 and the rim 906 to prevent rotation and allow torque to betransferred therebetween. As the handle 900 is rotated about the axis ofits distal end 904, torque is transmitted to the patient's hand by thehandle cover 908 that is gripped by the patient's hand.

The sterile connection 600, clip 700, and sterile wrap 800, oralternatively the sterile connection 1600, the clip 1700, and thesterile wrap 800, securely attach the patient's limbs to non-sterilesupport devices, such as a surgical arm positioning system 8. Byattaching the patient's limbs to the sterile connection 600, oralternatively the sterile connection 1600, and attaching the sterileconnection 600, or alternatively the sterile connection 1600, tonon-sterile support devices, a single sterile staff member can attachthe patient's sterilely prepared limb to the non-sterile support devicewithout assistance from non-sterile personnel. The sterile operator canhold the sterile part of the receiving assembly 610 and place theconnector hook 630 around the pin 642 of the cable adaptor 636 to attachthe receiving assembly 610 to the cable adaptor 636 without touchingnon-sterile components. Alternatively, the sterile operator can hold thesterile part of the receiving assembly 1610 and place the connector hook1630 around the pin 642 of the cable adaptor 636 to attach the receivingassembly 1610 to the cable adaptor 636 without touching non-sterilecomponents. The sterile connection 600 and its use can save manpower byallowing a single person to connect the patient's arm to the non-sterilesupport device and reducing the chance of breaking sterility. Thesterile connection 600 and its use can also save cost by limiting theamount of disposable material required to attach the patient's arm tothe non-sterile support device.

The sterile connection 600, clip 700, and sterile wrap 800, oralternatively the sterile connection 1600, the clip 1700, and thesterile wrap 800, provide several additional benefits. Attaching asterile connection 600 to a support system having two cable ends 640provides the advantage of allowing for arm angle adjustability. Thesterile connection 600 is easy to attach and detach to a support device.Also, the sterile connection 600 can be detached by an operator whilemaintaining sterility. The sterile connection 600 resists accidentaldecoupling. The sterile connection 600 does not require the patient'slimb to be secured against rigid components, thereby addressing concernsof pressure points.

Although certain illustrative embodiments have been described in detailabove, variations and modifications exist within the scope and spirit ofthis disclosure as described and defined in the following claims.

The invention claimed is:
 1. A surgical arm positioning systemcomprising: a frame having a first frame member and a second framemember; when mounted to a surgical table that is lying horizontally, thesecond frame member being supported with respect to the first framemember to form an obtuse angle between the first frame member and thesecond frame member, the first frame member having a first longitudinalaxis, the second frame member having a second longitudinal axis, whereinthe first longitudinal axis intersects the second longitudinal axis whenmounted to the surgical table such that the first longitudinal axis andsecond longitudinal axis lie in the same vertically oriented plane; acable having two end portions coupled to a connection member of a handgrip such that the cable and connection member form a continuous loop, aplurality of pulleys including a first pulley movable along the firstframe member and a second pulley movable along the second frame member,wherein the first and second pulleys are linked to that the first andsecond pulleys move in unison along the respective first and secondframe members, wherein the continuous loop is trained around theplurality of pulleys, and a tensile resistance member engaged with thecable for providing tensile force to the cable thereby to resistmovement of the continuous loop.
 2. The surgical arm positioning systemof claim 1, wherein the tensile resistance member is a clutch providinga resistive torque to one of the pulleys.
 3. The surgical armpositioning system of claim 1, further comprising a weight engaged withthe cable.
 4. The surgical arm positioning system of claim 1, whereinthe two end portions form an angle from about 120 to about 180 degreesat the connection member.
 5. The surgical arm positioning system ofclaim 1, wherein when a patient's arm is attached to the connectionmember, the cable resists movement along the pulleys to keep thepatient's arm stationary after the patient's arm is placed at anyposition having between about 0 degrees and about 30 degrees of armabduction.
 6. The surgical arm positioning system of claim 1, wherein athird pulley of the plurality of pulleys is mounted at a fixed locationrelative to the frame.
 7. The surgical arm positioning system of claim6, wherein at least one of the first and second pulleys is coupled to abracket that resists movement along the frame.
 8. The surgical armpositioning system of claim 1, further comprising a semi-locked clampconfigured to permit pivoting a frame.
 9. The surgical arm positioningsystem of claim 8, wherein the semi-locked clamp provides resistance torotation of the frame.
 10. The surgical arm positioning system of claim1, further comprising a lower pulley bracket to which the first pulleyis coupled and an upper pulley bracket to which the second pulley iscoupled, wherein when a patient's arm is attached to the connectionmember, the lower and upper pulley brackets resist movement relative tothe frame to keep the arm stationary and the lower and upper pulleybrackets move relative to the frame in response to moving a patient'sarm.
 11. The surgical arm positioning system of claim 10, whereinmovement of one of the lower and upper pulley brackets influencesmovement of the other of the lower and upper pulley brackets.
 12. Thesurgical arm positioning system of claim 11, wherein a distance betweenthe lower and upper pulley brackets is fixed.
 13. The surgical armpositioning system of claim 12, further comprising a connecting rodfixing the distance between the lower and upper pulley brackets andlinking the first and second pulleys.
 14. The surgical arm positioningsystem of claim 10, wherein the lower pulley bracket and the upperpulley bracket each extend from a respective channel formed in thecorresponding first and second frame member.
 15. The surgical armpositioning system of claim 14, wherein the tensile resistance membercomprises a clutch providing a resistive torque to one of the pulleys.16. The surgical arm positioning system of claim 14, wherein the tensileresistance member comprises a weight.
 17. The surgical arm positioningsystem of claim 14, wherein the cable resists movement along saidpulleys and the lower and upper pulley brackets resist movement alongthe frame to keep the patient's arm stationary after the patient's armis placed at any position having between about 0 degrees and about 70degrees of arm abduction.
 18. The surgical arm positioning system ofclaim 10, further comprising a semi-locked clamp configured to permitpivoting of the frame.
 19. The surgical arm positioning system of claim18, wherein the semi-locked clamp provides resistance to rotation of theframe.
 20. The surgical arm positioning system of claim 1, furthercomprising a lower assembly and an upper assembly each carrying arespective one of the first and second pulleys, the lower and upperassemblies being adjustable along the frame, and a connecting rodcoupled to the lower and upper assemblies to maintain a substantiallyfixed distance between the lower and upper assemblies.
 21. The surgicalarm positioning system of claim 20, wherein the tensile resistancemember comprises a clutch providing a resistive torque to at least oneof the pulleys.
 22. The surgical arm positioning system of claim 20,wherein the tensile resistance member comprises a weight.
 23. Thesurgical arm positioning system of claim 20, wherein the two endportions form an angle from about 120 to about 180 degrees at theconnection member.
 24. The surgical arm positioning system of claim 20,wherein the connecting rod that maintains the substantially fixeddistance between the lower and upper assemblies pivots relative to theupper and lower assemblies as the lower and upper assemblies move alongthe frame.
 25. The surgical arm positioning system of claim 20, whereinwhen a patient's arm is attached to the connection member, the cableresists movement along said pulleys and the lower and upper assembliesresist movement along the frame to keep the patient's arm stationaryafter the patient's arm is placed at any position having between about 0degrees and about 70 degrees of arm abduction.
 26. The surgical armpositioning system of claim 20, further comprising a semi-locked clampconfigured to permit pivoting of the frame.
 27. The surgical armpositioning system of claim 26, wherein the semi-locked clamp providesresistance to rotation of the frame.